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Alkylbenzene Sulfonates Registration Review Team

Human Health & Environmental Effects

Nate Mottl

Zoë Layton

Srinivas Gowda

Najm Shamim

Pat Jennings

Steve Malish

Risk Management

Jacqueline Hardy

Wanda Henson

Office of General Counsel

Philip Ross
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Table of Contents

1 Introduction............................................................................................................................. 5

1.1 Statutory and Regulatory Authority ................................................................................. 5

1.2 Updates to the Work Plan................................................................................................. 6

1.3 Case Overview ................................................................................................................. 7

1.4 Chemical Identification and Properties............................................................................ 7

1.5 Use/Usage Description..................................................................................................... 9

1.5.1 Registrations ............................................................................................................. 9

1.5.2 Summary of Registered Uses.................................................................................... 9

1.5.3 Usage Information .................................................................................................. 11

1.6 Regulatory History ......................................................................................................... 11

1.6.1 Recent/Pending Regulatory Actions....................................................................... 11

1.6.2 Tolerance Information ............................................................................................ 11

1.7 Incidents......................................................................................................................... 12

1.7.1 Human Health ......................................................................................................... 12

1.7.2 Ecological ............................................................................................................... 12

2 Anticipated Data Needs...................................................................................................... 12

3 Human Health Risk Assessment........................................................................................... 14

3.1 Existing Toxicological Endpoints.................................................................................. 14

3.2 Dietary Exposure............................................................................................................ 16

3.2.1 Food ........................................................................................................................ 16

3.2.2 Drinking Water ....................................................................................................... 19

3.3 Occupational and Residential Exposures....................................................................... 19

3.3.1 Occupational Handler Exposure ............................................................................. 19

3.3.2 Residential Exposures............................................................................................. 21

3.4 Aggregate and Cumulative Exposure............................................................................. 21

3.4.1 Aggregate Exposures.............................................................................................. 21

3.4.2 Cumulative Exposures............................................................................................ 21

4 Environmental Risk Assessment........................................................................................... 21

4.1 Environmental Fate and Transport................................................................................. 21

4.2 Environmental Conceptual Model Exposure Pathways................................................. 23

4.2.1 Mechanism of Action.............................................................................................. 25

4.2.2 Measures of Effect (Ecotoxicology Endpoints)...................................................... 25

4.3 Exposure Analysis Plan.................................................................................................. 27

4.3.1 Aquatic and Terrestrial Wildlife Exposure Estimates ............................................ 27

4.3.2 Human Health Drinking Water Exposure Estimates.............................................. 28

4.4 Effects Analysis Plan ..................................................................................................... 28

4.5 Endangered Species Determination ............................................................................... 28

5 Endocrine Disruptor Screening Program (EDSP)................................................................. 29

6 Optional Label Changes........................................................................................................ 29

7 Next Steps............................................................................................................................. 30

8 References............................................................................................................................. 31

Appendix A Toxicology Profile............................................................................................... 33

Appendix B Dietary Profile ..................................................................................................... 52

Appendix C Environmental Fate ............................................................................................. 53
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Appendix D Ecotoxicology Profile.......................................................................................... 59

Appendix E Comments Received Concerning the Preliminary Work Plan............................ 63

List of Tables

Table 1 – Summary of Anticipated Risk Assessments and Data Needs: ABS............................... 5

Table 2 – Anticipated Registration Review Schedule for ABS...................................................... 6

Table 3 – Chemical Identification of Alkylbenzene Sulfonates..................................................... 7

Table 4 – Physical-Chemical and Fate Properties for Alkylbenzene Sulfonates............................ 8

Table 5 – Distribution of Products by Specific Alkylbenzene Sulfonate ....................................... 9

Table 6 – Summary of ABS Registered Uses................................................................................. 9

Table 7 – Existing Regulations for dodecylbenzene sulfonic acid (PC Code 098002)................ 11

Table 8 – Existing Regulations for sodium dodecylbenzene sulfonate (PC Code 079010)......... 12

Table 9 – Studies Anticipated as Needed for the Registration Review of ABS........................... 13

Table 10 – Existing Toxicological Endpoints............................................................................... 14

Table 11 - Alkylbenzene Sulfonate Labels with Fruit and Vegetable Wash Uses....................... 18

Table 12 – Occupational Handler Exposure Scenarios for ABS .................................................. 20

Table 13 – Existing Effects Endpoints for Risk Assessment of ABS........................................... 26

Table 14 – Acute Toxicity Studies for ABS ................................................................................. 33

Table 15 – Subchronic/Chronic and Other Toxicity Studies........................................................ 42

Table 16 – Endpoints to be Reevaluated Using the Most Current Acceptable Data .................... 48

Table 17 - Abiotic Degradation of ABS ....................................................................................... 54

Table 18 - Biotic Degradation of ABS ......................................................................................... 55

Table 19—Estimated Physical Properties..................................................................................... 55

Table 20 – Available Endpoints from Avian Ecotoxicity Studies for Sodium Dodecylbenzene 

Sulfonate ....................................................................................................................................... 59

Table 21 – Available Endpoints from Freshwater Fish Ecotoxicity Studies for LAS.................. 60

Table 22 – Available Endpoints from Freshwater Invertebrate Ecotoxicity Studies for LAS ..... 61

Table 23 – Available Endpoints from Freshwater Aquatic Plants................................................ 61

List of Figures

Figure 1 – Conceptual Model for Ecological Exposure and Effects of Dodecylbenzene Sulfonic 

Acid and its Reaction Products/Degradates from Indoor Food and Non-food Use Sanitizers 

Ecological Effects Assessment ..................................................................................................... 24

Figure 2 – Conceptual Model for Ecological Exposure and Effects of Sodium Dodecyl Sulfonate 

and its Reaction Products/Degradates from Antimicrobial Fruit and Vegetable Washes and Food 

Contact Sanitizer........................................................................................................................... 25
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1 Introduction 

This document is the Environmental Protection Agency’s (EPA or “the agency”) Final Work 

Plan (FWP) for Alkylbenzene Sulfonates (ABS). The FWP document explains what EPA's 

Office of Pesticide Programs knows about ABS, highlighting anticipated data and assessment 

needs, identifying the types of information that would be especially useful to the Agency in 

conducting the review, and providing an anticipated timeline for completing their review. This 

work plan also addresses public comments received concerning the Preliminary Work Plan 

(PWP), which was posted in the Alkylbenzene Sulfonates registration review docket (EPA-HQOPP-2013-0097). Further, this document makes final the work plan for the Alkylbenzene 

Sulfonates registration review process.

1.1 Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States generally must be registered by the U.S. 

Environmental Protection Agency (USEPA, EPA, or the Agency) based on scientific data 

showing that they will not cause unreasonable risks to human health or the environment when 

used as directed on product labeling. The registration review program is intended to make sure 

that, as the ability to assess risk evolves and as policies and practices change, all registered 

pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, the Agency periodically reevaluates 

pesticides to make sure that as change occurs, products in the marketplace can be used safely. 

Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/.

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The regulations governing registration review begin at 40 CFR 155.40. The Agency 

will consider benefits information and data as required by FIFRA. The public phase of 

registration review begins when the initial docket is opened for each case. The docket is the 

Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses 

and data or information it believes are needed to make a registration review decision. The PWP 

published on March 27, 2013 and the comment period ended May 27, 2013.

Documents associated with this registration review can be viewed at http://www.regulations.gov 

in docket EPA-HQ-OPP-2013-0097. Below is a summary of the issues relevant to this 

registration review case. 

Table 1 – Summary of Anticipated Risk Assessments and Data Needs: ABS

Risk Assessment 

Assessment 

Necessary to Support 

Registration Review

Date of Most 

Recent 

Assessment

Type of Assessment 

Required 

(New/Updated)

Data Anticipated as 

Needed (See Table 9

for details)

Dietary (food) Yes 2006 Updated Residue Chemistry

Dietary (drinking water) No (see See 3.2.2) None None None

Occupational Handler

(Inhalation/Exposure) Yes 2006 Updated Inhalation Exposure
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Risk Assessment 

Assessment 

Necessary to Support 

Registration Review

Date of Most 

Recent 

Assessment

Type of Assessment 

Required 

(New/Updated)

Data Anticipated as 

Needed (See Table 9

for details)

Residential Handler No (see Section 3.3.2) None None None

Aggregate Yes None New Residue Chemistry

Inhalation Exposure 

Cumulative No (see Section 3.4.2) None None None

Tolerance Review No (see Section 1.6.2) None None None

Ecological No1 (see Section 4) None None None 1 A hazard assessment for discharge to wastewater treatment plants will be conducted but given the extensive 

literature open literature available on LAS no additional data is anticipated to be required to perform this 

assessment.

Table 2 – Anticipated Registration Review Schedule for ABS

Anticipated Activity Target Date* Completion Date

Phase 1: Opening the Docket 

Open Docket and 60-Day Comment Period for Preliminary Work Plan 2013-03 2013-03-27

Close Public Comment Period 2013-05 2013-05-27

Phase 2: Case Development 

Issue Final Work Plan 2013-09

Issue Data Call-In (DCI) 2014-09

Receive Data to be Considered in Risk Assessment 2016-09

Open 30-Day Public Comment Period for Preliminary Risk 

Assessment(s) 2018-03

Close Public Comment Period 2018-04

Phase 3: Registration Review Decision and Implementation 

Open 60-Day Public Comment Period for Proposed Decision 2018-09

Close Public Comment Period 2018-11

Issue Final Decision 2019-03

Begin Post-Decision Followup 2019

Total (years) 6

*The anticipated schedule will be revised as necessary (e.g., need arising under the Endocrine Disruptor Screening Program with 

respect to the active ingredients in this case).

1.2 Updates to the Work Plan

Since the publication of the PWP, the agency has made the following updates:

• Added Updates to the Work Plan section.

• Updated the dates in Table 2.

• Removed the Guidance for Commenters Section

• Added Appendix E “Comments Received Concerning the Preliminary Work Plan.”

• Updated the application rates under Table. These updates were made in response to 

comments received during the public comment period (see Appendix E).

The Agency received one comment on the initial docket. The comment received did not affect 

the data needs of the work plan and timeline described in the PWP. A summary of the comment

received and the Agency’s responses are presented in Appendix E.
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1.3 Case Overview

The docket for the Alkylbenzene Sulfonates Case (Case 4006) has been established at 

http://www.regulations.gov in docket number EPA-HQ-OPP-2013-0097. Except where 

otherwise noted, the active ingredients in this case will be referred to collectively as 

“alkylbenzene sulfonates” or “ABS”.

The alkylbenzene sulfonates are registered for use as food-contact sanitizers in food processing 

plants and eating establishments. They are also registered for use as disinfectants and sanitizers 

for agricultural, commercial, institutional, industrial, and public access uses. However, the 

largest overall use of alkylbenzene sulfonates is as surfactants in household laundry and dish 

detergents, which do not make pesticidal claims and are not part of this assessment. In examining 

aggregate exposure, EPA takes into account the available and reliable information concerning 

exposures to pesticide residues in food and drinking water, and non-occupational pesticide

exposures. The aggregate exposure does not take into consideration non-pesticidal uses.

The Alkylbenzene Sulfonates (ABS) Case originally included three antimicrobial compounds as

follows: 

• Sodium dodecylbenzene sulfonate (PC Code: 079010); 

• Dodecylbeneze sulfonic acid (PC Code: 098002) and; 

• C10-16 alkylbenzene sulfonic acid (PC Code: 190116).

All registrations containing C10-16-alkylbenzene sulfonic acid (PC Code: 190116) have been 

voluntarily cancelled as of February 6, 2013. Therefore, C10-16-alkylbenzene sulfonic acid will 

no longer be assessed under this registration review case. 

1.4 Chemical Identification and Properties

Table 3 presents the two active ingredients to be assessed in Case 4006: Sodium dodecylbenzene 

sulfonate (PC Code: 079010) and Dodecylbenzene sulfonic acid (PC Code: 098002). The major 

difference between these actives are the ions on the sulfonate groups which are sodium versus 

hydrogen respectively, both ionize. ABS product chemistry information relevant to risk 

assessment is summarized in Table 4.

Table 3 – Chemical Identification of Alkylbenzene Sulfonates

Chemical Name Sodium dodecylbenzenesulfonate Dodecylbenzenesulfonic acid

Classification Linear alkylbenzene sulfonates (LAS) Linear alkylbenzene (LAB) Sulfonic Acid

PC Code 079010 098002

CAS No. 25155-30-0 27176-87-0

Molecular Formula C18H29NaO3S C18H30O3S

Molecular Weight 348.48 g/mol 326.49 g/mol

Molecular Structure
Page 8 of 63

Table 4 – Physical-Chemical and Fate Properties for Alkylbenzene Sulfonates

OPPTS 

Guideline 

No.

Physical and 

Chemical 

Properties

Sodium dodecylbenzenesulfonate Dodecylbenzenesulfonic acid

830.1550 Product identity 

and composition Refer to Table 3. Refer to Table 3.

830.1650

Description of 

Formulation 

Process

Confidential Business Information (CBI) CBI

830.6302 Color White to light yellow flakes, granules, or 

powder. Colorless liquid / Light yellow to brown

830.6303 Physical State Crystalline powder Colorless liquid.

830.6304 Odor No discernible odor No discernible odor

830.6313 

Stability to 

sunlight, normal 

and elevated 

temperature, 

metals/metal ions 

Stable under normal temperature. Stable under normal temperature.

830.7000 pH 7.5 – 10.5 1% aqueous solution at 25°C. <1

830.7050 UV/Visible 

Absorption 

Highly susceptible to photodegradation.

Stability to Sunlight: 80% photodegrade at 

223 nm within 10 hours.

215 nm.

Highly susceptible to photodegradation.

830.7100 Viscosity Not applicable for solids. 890 cP at 25°C

Viscous Liquid

830.7200 Melting point 287.63°C Not applicable. It is a liquid

830.7220 Boiling point Not applicable. It is a solid. 205°C 

830.7300 Density 1.0 at 20°C for 60% slurry.

1.06 (kg/l) (relative) 1.06 g/mL at 20 °C

830.7370 Dissociation 

Constant 

In aqueous solution at neutral pH solutions 

of LAS, where the sodium ion will 

disassociate to form the LAS anion (linear 

alkyl benzene-SO3 ̄). 

pKa: 4.19 (25 oC)

: 4.12 (20 oC)

The LAB sulfonic acids are strong acids 

(pKa <1) that are completely ionized in 

aqueous solutions. The chemical 

species present in aqueous solutions is 

the LAS ion (linear alkyl benzene-SO3

-

).

830.7550 

Partition 

coefficient (noctanol/water) 1.96 1.96

830.7840 Solubility in water 

LAS is made up of a polar (hydrophillic) 

group, -SO3

- and a nonpolar (hydrophobic) 

long-chain aliphatic group. It disperses in 

water to form micelles rather than 

dissolving. The dispersion saturation point 

at 25oC is 30-35 g/mL.

This ai is made up of a polar 

(hydrophillic) group, -SO3

- and a 

nonpolar (hydrophobic) long-chain 

aliphatic group. It disperses in water to 

form micelles rather than dissolving.

830.7950 Vapor pressure 2.29 x10-15 mm Hg at 25 °C (Source: EPI 

Suite)

7.93 x 10-11 mm Hg at 25° C (Source: 

EPI Suite)

Source: MRIDs, 00161996, 00161997, 00162297, 41221301, 42439801, 43377801, 43656401, 43656402, 

43656403, and 43787401, HPV, and EPI Suite v4.1
Page 9 of 63

1.5 Use/Usage Description

1.5.1 Registrations

There are 12 registered products that contain alkylbenzene sulfonates. The distribution of 

products by specific alkylbenzene sulfonates is presented in Table 5. Most of the products are 

formulated as flakes, granules, powder and liquids.

Table 5 – Distribution of Products by Specific Alkylbenzene Sulfonate

Chemical Name PC 

Code % ai Formulations Registered Products

Sodium 

dodecylbenzene 

sulfonate

079010 0.036-

3.6%

Soluble Concentrate; 

Ready to Use 1677-234, 71094-1, 71094-2

Dodecylbeneze 

sulfonic acid 098002 2.93-

17.46% Soluble Concentrate

1677-56, 19713-299, 4959-29, 63838-14, 

65001-1, 875-184, 875-185, 875-85, 

71695-1

Three registered products contain the active ingredient sodium dodecylbenzene sulfonate (PC 

Code: 079010). All three of these products are registered as antimicrobial fruit and vegetable 

treatments for use to reduce pathogens and control spoilage and decay caused by 

microorganisms. The fruit and vegetable washes are used in food retail eating establishments 

such as restaurants, cafeterias, food service operations, commissaries, and kitchens. Additionally, 

two of the three products containing sodium dodecylbenzene sulfonate (Reg #s 71094-1 and 

71094-2) are registered for use as food-contact sanitizers to control bacteria on sinks, drain and 

cutting boards, counter tops, forks, knives, dishes, utensils, and salad preparation surfaces in 

kitchens, restaurants, other eating establishments, dairies, and food processing plants.

Nine registered products contain the active ingredient dodecylbenzene sulfonic acid (PC Code: 

098002). The products are registered for use as indoor food and non-food use sanitizers for 

various sites including dairy farm milking machines and milk handling equipment and facilities, 

dairy and cheese processing plant equipment, ice cream processing plant equipment, egg 

processing and packaging equipment and surfaces, eating establishments (including equipment, 

glassware and utensils), food processing equipment and surfaces, meat and poultry processing 

plants, carbonated beverage and brewery processing equipment and surfaces, winery and 

brewery processing equipment and surfaces, and seafood processing plants. 

1.5.2 Summary of Registered Uses 

Table 6 presents a summary of the registered uses of Alkylbenzene Sulfonates that will be 

assessed in this registration review. Alkylbenzene Sulfonates can be applied by the following 

application methods: 

Table 6 – Summary of ABS Registered Uses

Site Category Registration # Application Method Application 

Rate 

Fruit & Vegetable Wash

71094-1

Brush, flood treatment, foam 

application, Immersion, 

Spray, Wipe

1 oz/8 gal or 

2oz/4gal

71094-2 Agitation, Drip, Scrub, Spay 1 unspecified

1677-234 Agitation 1 oz/1 gal

Commercial Transportation Facilities 875-85 Spray 2 oz/2 gal
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Site Category Registration # Application Method Application 

Rate 

Commercial/Industrial/Institutional Premises 

and Equipment 1677-234 Agitation 1 oz

Dairy Farm Milk Handling Facilities and 

Equipment

1677-56 Immersion, (Spray) 1 oz/ 2 gal or 

(1oz/1 gal)

19713-299 Spray 1 oz/5 gal

4959-29 Flush, Spray 1 oz/5 gal

63838-14 Brush, Dip, Spray 1 oz/5 gal

65001-1 Immersion, Mop, Spray, 

Sponge 1 oz/5 gal

875-184 Circulation, Flush, 

Immersion, Spray 1oz/6 gal

875-185 Flood, Foam, Immersion, 

Spray 2.5 oz/4 gal

875-85

Circulation, , Immersion, 

(Spray), Mop Wipe on, , 

Flood, Foam, Brush

1oz/2 gal or (2 

oz/2 gal)

Eating Establishments

65001-1 Immersion, Mop, Spray, 

Sponge 1 oz/5 gal

875-184 Spray, Circulation,

Immersion, Flush 1oz/6 gal

875-185 Spray, Foam, Flood, 

Immersion, 2.5 oz/4 gal

875-85

Spray, Circulation, 

Immersion, Mop, Wipe, 

Foam, Flood, Brush, 

1- oz/ 2 gal

Egg Handling Facilities and Equipment

875-184 Flush, Spray, Circulation, 

Immersion 1 oz/6 gal

875-185 Foam, Flood, Immersion, 

Spray 2.5 oz/4 gal

Food Processing Plant Premises/Equipment

19713-299 Spray 1 oz/5 gal

4959-29 Brush, Soak, Spray 1 oz/5 gal

63838-14 Brush, Dip, Spray 1 oz/5 gal

65001-1 Immersion, Mop, Spray, 

Sponge 1 oz/5 gal

875-184 Spray, Circulation 

,Immersion, Flush 1 oz/6 gal

875-185 Spray,, Flood, Foam

Immersion, 2.5 oz/4 gal

875-85

Brush, Circulation, Flood, 

Immersion, , (Spray) Mop, 

Wipe, Foam

1 oz/2 gal (2 

oz/2 gal

1677-56 Spray 1 oz/1 gal

Food/Grocery 

Marketing/Storage/Distribution Facility 

Premise

19713-299 Spray 1 oz/5 gal

875-184 Spray, Circulation, 

Immersion, Flush 1 oz/6al

875-185 Spray, Foam, Flood , 

Immersion 2.5 oz/4 gal

875-85

Circulation, Immersion, 

(Spray), Mop, Wipe, Flood, 

Foam, Brushing

1 oz/2 gal or 

(2oz/2 gal)

Tanks, Tank Trucks, Silos, Vats, Pails, 

Pipelines and Closed Systems 19713-299 Spray 1 oz/5 gal

Bathroom Premises/Hard Surfaces 65001-1 Sponge, Wipe, Spray 1 oz/5 gal
Page 11 of 63

1.5.3 Usage Information 

The alkylbenzene sulfonates are registered for use as disinfectants and both food and non-food 

sanitizers as summarized in Table 6.

The alkylbenzene sulfonates are listed on the Office of Pollution Prevention and Toxics 

(OPPT)’s High Production Volume (HPV) Challenge Program1. HPV chemicals are those that 

are manufactured or imported into the U.S. in production volumes greater than one million 

pounds per year. Approximately 10 million pounds of alkylbenzene sulfonates are used in EPA 

registered antimicrobial products according to the Section Seven Tracking System for the years 

2001-2010.

1.6 Regulatory History

The first product containing Sodium dodecylbenzene sulfonate (PC Code 079010) as an active 

ingredient was registered in the United States in 1968. The first product containing 

dodecylbenzene sulfonic acid (PC Code 098002) as an active ingredient was registered in the 

United States in 1969. The Agency completed a Reregistration Eligibility Decision (RED) for 

ABS in 2006.

1.6.1 Recent/Pending Regulatory Actions

There are currently no pending registrations for the alkylbenzene sulfonates case.

1.6.2 Tolerance Information

Dodecylbenzenesulfonic acid (098002) and sodium dodecylbenzene sulfonate (079010) have 

uses in food-contact surface sanitizing solutions with tolerance exemptions specified in 40 CFR 

180.940(b) and (c) respectively, and food additive regulations established by FDA under FFDCA 

Sec. 409, which are summarized in Table 7 and Table 8. Residues for these compounds from the 

food-contact surface sanitizing solution are exempt from the requirements of a tolerance when 

used in accordance with good manufacturing practices as ingredients in antimicrobial pesticide 

formulation, provided that the substance is applied on a semi-permanent or permanent foodcontact surface (other than being applied on food packaging) with adequate draining before 

contact with food. Both dodecylbenzenesulfonic acid (098002) and sodium dodecylbenzene 

sulfonate (079010) have limitations for the ready-to-use end-use concentration not to exceed 400 

ppm and 430 ppm, respectively, for food processing equipment and utensils. However, 

dodecylbenzene sulfonic acid has a much lower limitation of 5.5 ppm for use on dairy processing 

equipment. The 2006 RED states that, “the agency will be proposing a change to the 40 CFR 

180.940(b) to have the end-use concentration not to exceed 400 ppm, rather than the current 

limitation of 5.5 ppm”, the agency anticipates making this change to 40 CFR 180.940(b). 

Table 7 – Existing Regulations for dodecylbenzene sulfonic acid (PC Code 098002)

Regulation Allowed Use Site Limit

21 CFR 178.1010(b)(7) and 

178.1010(c)(5)

food-processing equipment and utensils, glass bottles and other glass 

containers intended for holding milk

400 

ppm

21 CFR 178.1010 (b)(10) and food-processing equipment and utensils and other food-contact 400 

 1 EPA (U.S. Environmental Protection Agency). 2006. Assessment Plan for the Linear Alkylbenzene (LAB) 

Sulfonic Acids Category in Accordance with the USEPA High Production Volume Chemical Challenge Program. 

EPA 201-14485A. Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Washington, 

DC. May 20, 2003.
Page 12 of 63

Regulation Allowed Use Site Limit

178.1010 (c)(7) articles, beverage containers except milk containers or equipment ppm

21 CFR 178.1010(b)(40) and 

178.1010(c)(35) dairy processing equipment 5.5 ppm

40 CFR 180.940 (c) food-processing equipment and utensils 400 

ppm

40 CFR 180.940 (b) dairy processing equipment, and food-processing equipment and 

utensils

5.5 

ppm

Table 8 – Existing Regulations for sodium dodecylbenzene sulfonate (PC Code 079010)

Regulation Allowed Use Sites Limit

21 CFR 178.1010(b)(21) and 

178.1010(c)(16)

food-processing equipment and utensils, glass bottles and other 

glass containers intended for holding milk 430 ppm

40 CFR 180.940 (c) food-processing equipment and utensils 430 ppm

21 CFR 173.315 to wash or to assist in the peeling of fruits and vegetables (no 

potable water rinse required)

0.2% in wash 

water

1.7 Incidents

1.7.1 Human Health

From 1999 to 2006 there were twelve human exposure incidents that were recorded in the OPP 

Incident Data System (IDS) which could be attributed to alkylbenzene sulfonates products. 

Irritation concerns were the primary effect, but may be due to other more irritating chemicals that 

were also included in the products such as acids and quaternary ammonium compounds. 

Therefore, the agency cannot attribute the incidents to alkylbenzene sulfonates.

1.7.2 Ecological

No reported incidents from registered use in the agency's Ecological Incident Information System

(EllS).

2 Anticipated Data Needs

Table 9 presents a summary of the data anticipated as being needed to support this registration 

review.
Page 13 of 63

Table 9 – Studies Anticipated as Needed for the Registration Review of ABS

GLN Study Name Test 

Substance

Time Frame 

(Months)

(Measured in months 

from DCI Receipt)

Risk 

Assessment(s) 

Data Will 

Support

Use Site(s) 

Triggering 

Anticipated 

Data 

Requirement

Applicable 

Exposure 

Scenarios

Studies Anticipated to be Required through the Registration Review DCI

875.1700 Product Use 

Information 

TEP 12 All All All 

Scenarios 

860.1500 Residue in 

Crops2

TEP 24 Dietary Fruit and 

Vegetable 

Wash

Chronic 

dietary

Studies Expected to be Required through the Anticipated Post-RED DCI

870.3465 90-day 

Inhalation 

Toxicity 

TGAI 24 Occupational Hard Surface 

Disinfection, 

Restaurants, 

and Food 

Processing 

Equipment

Trigger 

Spray, 

Low 

Pressure 

Spray, and 

Mopping

875.1400 Inhalation 

ExposureIndoor3

TEP 24 Occupational Hard Surface 

Disinfection, 

Restaurants, 

and Food 

Processing 

Equipment

Trigger 

Spray, 

Low 

Pressure 

Spray, and 

Mopping

875.1600 Application 

Exposure 

Monitoring 

Data Reporting

TEP 24 Occupational Hard Surface 

Disinfection, 

Restaurants, 

and Food 

Processing 

Equipment

Trigger 

Spray, 

Low 

Pressure 

Spray, and 

Mopping

875.2800 Description of 

Human 

Activity

TEP 12 Occupational Hard Surface 

Disinfection, 

Restaurants, 

and Food 

Processing 

Equipment

Mopping

 2 Residue trails (860.1500) are expected to be necessary for the following representative fruits and vegetables: 

Artichoke, Broccoli, Cantaloupe, Sweet Pepper, Loose-head Lettuce, Mushrooms, Blackberry, and Apricot to 

determine dietary exposure to ABS following fruit and vegetable washing.

3 Indoor exposure data are expected to be needed for the following occupational handler scenarios: 1- Open pour 

liquids and powder, mop, wipe, low pressure spray and trigger spray for hard surface disinfection and food 

processing equipment 2- Open pour, wiping and brushing for restaurant equipment dishes, glasses, utensils and other 

food handling equipment 3- Immersion of hands for fruit and vegetable wash or sanitizing pots, pans, etc., 4- Open 

pour for circulate in place for food processing plants. The label uses are for commercial and institutional uses only 

and there are no residential uses. Therefore, no residential handler or post-application assessments are expected to be 

needed.
Page 14 of 63

3 Human Health Risk Assessment

The Agency anticipates the need to conduct a human health risk assessment for ABS. The 

Agency expects to require additional data for use in conducting the registration review.

3.1 Existing Toxicological Endpoints 

The toxicological points of departure (PODs) for the alkylbenzene sulfonates are included in 

Table 10 and were established by the RED in 2006 based on the toxicity database. These PODs 

have not been updated. It should be noted that the there are no toxicological endpoints for dermal 

exposure and a dermal risk assessment will not be conducted in registration review. 

Table 10 – Existing Toxicological Endpoints 

Exposure

Scenario

Dose Used in Risk 

Assessment, UF

(mg/kg/day)

Special FQPA SF*, endpoint and Level of 

Concern for Risk Assessment

Study and 

Toxicological 

Effect

Acute Dietary

(females 13+)

No endpoint was selected. No effects are attributable to a single dose in animal studies.

Chronic 

Dietary

(All 

Populations)

Systemic/Reproductive

Oral NOAEL= 50 

mg/kg/day

UF-100

NOAEL= 40 mg/kg/day (0.07%) and LOAEL= 114 

mg/kg/day (0.2%) based on increased caecum 

weight and slight kidney damage in a 6 month rat 

dietary study (Yoneyama et al. 1972 Ann. Rep. 

Tokyo Metrop. Res. Lab. Public Health 24:409-440)

Systemic/Reproductive NOAEL= 50 mg/kg/day and 

LOAEL = 250 mg/kg/day based on decreased Day 

21 female pup body weight (Bueler, E. et al. 1971. 

Tox Appl. Pharmacol. 18:83-91)

NOAEL=85 mg/kg/day and LOAEL = 145 

mg/kg/day from 9 month drinking water rat study 

based on decreased body weight gain, and 

serum/biochemical and enzymatic changes in the 

liver and kidney (Yoneyama et al. 1976 Ann. Rep. 

Tokyo Metrop. Res. Lab Public Health 27(2): 105-

112.

6-month Oral 

Toxicity – Rat

Developmental 

Toxicity - Rat

9-month 

Drinking Water 

Study

Incidental 

Oral, ShortTerm

Oral NOAEL= 50 

mg/kg/day

UF-100

NOAEL= 40 mg/kg/day (0.07%) and LOAEL= 114 

mg/kg/day (0.2%) based on increased caecum 

weight and slight kidney damage in a 6 month rat 

dietary study (Yoneyama et al. 1972 Ann. Rep. 

Tokyo Metrop. Res. Lab. Public Health 24:409-440)

Systemic/Reproductive NOAEL= 50 mg/kg/day and 

LOAEL = 250 mg/kg/day based on decreased Day 

21 female pup body weight (Bueler, E. et al. 1971. 

Tox Appl. Pharmacol. 18:83-91)

NOAEL=85 mg/kg/day and LOAEL = 145 

mg/kg/day from 9 month drinking water rat study 

based on decreased body weight gain, and 

serum/biochemical and enzymatic changes in the 

liver and kidney (Yoneyama et al. 1976 Ann. Rep. 

Tokyo Metrop. Res. Lab Public Health 27(2): 105-

112.

6-month Oral 

Toxicity – Rat

Developmental 

Toxicity - Rat

9-month 

Drinking Water 

Study
Page 15 of 63

Exposure

Scenario

Dose Used in Risk 

Assessment, UF

(mg/kg/day)

Special FQPA SF*, endpoint and Level of 

Concern for Risk Assessment

Study and 

Toxicological 

Effect

Short- and 

IntermediateTerm 

(Dermal)

Not Required Quantification of dermal risk is not required since: 

1) the alkylbenzene sulfonates are surfactants that 

are dermal irritants at concentrations generally 

greater than 20% solution. Thus, dermal exposure 

would be self-limiting to preclude dermal irritation.

Additionally, the anticipated requirement of the 

dermal toxicity studies with the end-use product will 

determine and be used for the personal protective 

clothing necessary to protect against irritation during 

product use; 2) no systemic toxicity was seen 

following repeated dermal applications to rabbits at 

200 mg/kg/day (with an end use product), and 3) no 

developmental toxicity concerns were seen 

following repeated dermal applications to pregnant 

mice, rats or rabbits (developmental effects were 

seen either in the presence of maternal toxicity or at 

doses higher than those that caused maternal 

toxicity). 

Developmental 

Toxicity – Rat

Inhalation

(Any time 

point)

Inhalation study NOAEL= 

1mg/m3 detergent dust 

combined with up to 0.1 

mg/m3 enzyme dust

Equivalent to approximately 

0.14 mg/kg/day (a)

(inhalation absorption rate = 

100%)

purity= 13% active 

ingredient

UF-100

Subchronic Inhalation Monkey Study

LOAEL = 10 mg/m3 detergent combined with 0.1 

mg/m3 enzyme dust based on weight loss and 

decreased weight gain (W. Coates, et al 1978. Tox. 

Appl. Pharmacol. 45: 477-496) This air 

concentration is equivalent to approximately 1.4 

mg/kg/day (a)

Inhalation 

Toxicity – Rat

Cancer (oral, 

dermal, 

inhalation)

No evidence of carcinogenicity in reported studies in rats done before 1980 GLPs

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, 

LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = 

reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable

NOTE: No Special FQPA Safety Factor recommended because the exposure databases (dietary food, drinking 

water, and residential) are complete and the risk assessment for each potential exposure scenario includes all

metabolites and/or degradates of concern and does not underestimate the potential risk for infants and children.

(a) Equation used to convert inhalation air concentration to a dose= mg/L* absorption*respiratory volume 

(L/hr)*duration (hrs) * activity factor / body weight. Thus, 0.001 mg/L * 1*67.94 L/hr (based on default respiratory 

volumes for a New Zealand Rabbit which is used as a surrogate for a cynomolgus monkey) * 6 hrs * 1 / 2.98 kg 

(body weight for New Zealand Rabbit used as a surrogate for cynomolgus monkey, study reports monkey body 

weight ranges from 1.6 to 3.7 kg).
Page 16 of 63

3.2 Dietary Exposure 

3.2.1 Food

3.2.1.1 Food Use Patterns

Although antimicrobial products are not meant to be ingested, the use patterns summarized in 

table Table 6 may result in residues that remain on the surfaces of utensils, dishware, food 

processing equipment, and/or the food products themselves. Subsequent residues may be 

ingested in small amounts by consumers and therefore it is necessary to assess the risk of dietary 

consumption of alkylbenzene sulfonates. 

Food uses for alkylbenzene sulfonates can be categorized into two general use patterns: food 

contact surface sanitizers and fruit and vegetable washes.

3.2.1.1.1 Food-Contact Surface Sanitizers

Alkylbenzene sulfonates are used as sanitizers in various phases of food production including 

agriculture, food-processing, transportation, and eating areas. Agricultural areas include milking 

facilities and equipment, and egg packing equipment. In the food-processing phase, alkylbenzene 

sulfonates are used to sanitize facilities that process meat, poultry, seafood, eggs, beverages, 

wine, ice cream, cheese, and other dairy products. Sanitization of these facilities includes 

equipment such as conveyor belts, utensils, glassware, food handling/storage areas, premises, 

and transportation areas. Finally, alkylbenzene sulfonates are used to sanitize public eating 

places, including countertops, utensils, glassware, and food preparation equipment (a detailed list 

of uses for each chemical can be found in Table 6.

3.2.1.1.2 Fruit and Vegetable Wash

Human dietary exposure to alkylbenzene sulfonates residues may occur as a result of their use in 

fruit and vegetable rinses, both processed and raw agricultural commodities (RACs).

3.2.1.2 Dietary Risk Characterization

Dietary risk is characterized in terms of the Population Adjusted Dose (PAD). The PAD is a 

function of the Reference Dose (RfD) adjusted to account for the FQPA Safety Factor (SF). A 

Reference Dose is an estimate of a daily oral exposure to the human population that is likely to 

be without an appreciable risk of deleterious effects during a lifetime. The FQPA SF is intended 

to provide an additional 10-fold safety factor (10x) to protect for special sensitivity in infants and 

children to specific pesticide residues in food, drinking water, or residential exposures. A risk 

estimate that is less than 100% of the acute or chronic PAD is not of concern.

An acute dietary assessment for alkylbenzene sulfonates was not conducted because there are no 

adverse effects attributable to a single dose exposure in animal studies. 

A chronic dietary assessment for alkylbenzene sulfonates was conducted in the 2006 RED.

Chronic dietary risk for alkylbenzene sulfonates is assessed by comparing chronic dietary 

exposure estimates (in mg/kg/day) to the chronic Population Adjusted Dose (cPAD). Chronic 

dietary risk is expressed as a percentage of the cPAD. The cPAD is the chronic reference dose 

(0.5 mg/kg/day) modified by the FQPA safety factor. The chronic RfD is 0.5 mg/kg/day for all 

populations, using the NOAEL of 50 mg/kg/day based on the weight of evidence from three 

toxicological studies (Table 15) that observed decreased pup body weight at 250 mg/kg/day and 

increased caecum weight, slight kidney damage at 114 mg/kg/day and significant decreases in 
Page 17 of 63

renal biochemical parameters at 145 mg/kg/day. The NOAELs in the three studies used to 

develop the chronic endpoint are 40, 50 and 85 mg/kg/day and are shown in (Table 15). An 

uncertainty factor of 100 (10X for interspecies extrapolation, 10X for intraspecies variability) 

was applied to the NOAEL to obtain the chronic RfD. The alkylbenzene sulfonates cPAD is 0.5 

mg/kg/day based on a reference dose of 0.5 mg/kg/day, which includes the incorporation of the 

FQPA safety factor (reduced to 1X) for the overall U.S. population and all population subgroups.

3.2.1.3 Anticipated Dietary Risk Assessments 

Both exposure amounts and toxicity endpoints are necessary to assess the risk of alkylbenzene 

sulfonates. Risk must be assessed for both food-contact surface sanitizers as well as fruit and 

vegetable wash. The use patterns for alkylbenzene sulfonates with food-contact uses (Table 6) 

can be broadly categorized for risk assessment purposes: 

• Food contact sanitizing solutions

• Fruit and vegetable wash

3.2.1.3.1 Food Contact Sanitizing Solutions

Currently, the agency does not have data for residues of alkylbenzene sulfonates on treated food 

contact surfaces. In the absence of raw data, the agency has the ability to calculate residue levels 

that may occur in food from the application rates on food contact surfaces. In order to estimate 

the Estimated Daily Intake (EDI), the agency used a model calculation from FDA Guidelines 

(1993)4

. Due to the availability of this model, the agency does not anticipate requiring data for 

food contact sanitizing solutions. Variables necessary for the calculation include application rate, 

surface area to which food is exposed, fraction of pesticide migrating to food, and body weight.

Per the tolerance exemption for dodecylbenzene sulfonates, the maximum ingredient percentage 

(application rate) registered for use in food handling establishments in kitchens, cafeterias, 

supermarkets and meat and poultry plants is 400 ppm. The surface area to which food is exposed 

is assumed to be 4000 cm2 which is the summation of the surface area of utensils, china, and 

glass used by a person who regularly eats three meals a day. Pesticide migration to food is 

assumed to be 100%. Finally, based on the FDA’s accumulation of experimental residue data for 

sanitizers, a “worst case” assumption for residues is one milligram of sanitizer solution per 

square centimeter of treated surface. Using this assumption the following EDI values were 

calculated in the 2006 RED: 

• Adult Male: 22.9 μg dodecylbenzene sulfonate/kg/day

• Adult Female: 26.7 μg dodecylbenzene sulfonate/kg/day

• Child: 53 μg dodecylbenzene sulfonate/kg/day

The calculations presented in the 2006 RED assumed body weights of 15 kg for a 3 year old, 70 

kg for an adult male, and 60 kg for an adult female. These body weights have been replaced with 

11 kg for a 1-2 year old, 80 kg for an adult male, and 69 kg for an adult female (Exposure 

Factors Handbook. Vol 2, 2012). The new values will be used in the updated risk assessment. A 

detailed example of the calculations in the RED can be found on regulations.gov under docket 

EPA-HQ-OPP-2006-0156, memo entitled Dietary Risk Assessment for Alkylbenzene Sulfonates.

If the registrant disagrees with the approximation and/or assumptions, they may elect to provide 

 4 Ibid.
Page 18 of 63

their own experimental data. The agency does not anticipate calling in residue data for food 

contact sanitizing solutions. 

In the 2006 RED, the agency used a model calculation from FDA Guidelines (1993)5 to estimate 

residues in milk that would result from the use of alkylbenzene sulfonates in food processing 

equipment as representative of the potential uses in the food processing industry. As a 

conservative measure, the agency assessed the maximum application rate of 400 ppm for 

dodecylbenzene sulfonates, as listed on the labels, although the current tolerance exemption has 

a limitation of 5.5 ppm for dairy processing equipment. The agency estimated that use of this 

product results in maximum milk residues of 10 ppb (μg/kg).

3.2.1.3.2 Fruit and Vegetable Wash

As listed in Table 11, several alkylbenzene sulfonate labels include a use for washing fruit and 

vegetables.

Table 11 - Alkylbenzene Sulfonate Labels with Fruit and Vegetable Wash Uses

Registration 

Number Product Name PC Code Application Instructions

Potable 

Water 

Rinse

71094-1 PRO-SAN ® 079010

solution containing 1% (one pouch/8 gallons) or 

2% (1 pouch/4 gallons) of PRO-SAN ® powder to 

potable (drinking) water

Yes

71094-2 PRO-SAN L ® 079010

thoroughly wet the surface of fruits and vegetables 

by dipping in or spraying with PRO-SAN L ® 

solution

Yes

1677-234

Antimicrobial Fruit 

& Vegetable 

Treatment

079010

dilute Antimicrobial Fruit & Vegetable Treatment 

into the processing vessel by adding 0.75-1.00 

ounces of concentrate to a gallon of water

No

71695-1 CS-100 Anionic 

Sanitizer 098002

1 ounce of the product to 5 gallons of water (15.6 

mL to 10 L); at no time should the concentration of 

CS-100 Acid Anionic Sanitizer in the wash water 

exceed 2 ounces to 5 gallons (31.2 mL to 10L

Yes

FDA’s regulation at 21 CFR 173.315 permits this use provided that the wash solution does not 

contain dodecylbenzene sulfonic acid at a level greater than 0.2% (2,000 ppm), without a potable 

water rinse. It is presumed that the use limitation is for the parent chemical because the 

regulation makes no mention of formulations.

EPA Reg. Nos. 71094-1, 71094-2, and 71695-1 bear instructions that include a potable water 

rinse. However, there are no data showing that the level of residues on fruits and vegetables 

would be reduced to the level that would have occurred from 0.2% wash. The agency intends 

during registration review to work with registrants to update the labels for all four EPA 

registrations for fruit and vegetable washes to reflect application rates (ppm on an active 

ingredient basis). Application rates are necessary in order to conduct a dietary assessment of the 

fruit and vegetable wash use pattern.

In 2006, a dietary assessment was conducted for fruit and vegetable washes based on EPA Reg. 

No. 71695-1. The assessment was not based on residue data but on an assumption that the 

solution film thickness on a rinsed grape would be the same as that adhering to dishware surfaces 

rinsed after washing with a dishwashing product. As these uses are likely to result in measurable 

 5 Ibid.
Page 19 of 63

residues on raw agricultural commodities (RACs) and processed fruits and vegetables, EPA 

anticipates that residue trials treating RACs and processed fruits and vegetables will need to be 

conducted for risk assessment purposes. Residue trials (860.1500) are anticipated to be necessary 

for the following representative fruits and vegetables: 

• Artichoke

• Broccoli

• Cantaloupe

• Sweet Pepper

• Loose-head Lettuce

• Mushrooms

• Blackberry

• Apricot

3.2.2 Drinking Water 

It was determined in the 2006 RED that minimal or no drinking water risk is expected to occur 

due to the fact that the use patterns were considered indoors. has since been recognized that 

such use patterns may have an additional down-the-drain component resulting in potential 

releases to wastewater treatment plants (WWTPs) and subsequently the environment. Such 

releases for the linear 12 carbon chain ABS (C12-ABS) actives in this case are considered

highly unlikely to be discharged from WWTPs due to sorption and rapid biodegradation as

discussed in Section 4.1. Therefore no quantitative drinking water assessment is planned for

ABS.

3.3 Occupational and Residential Exposures

The Agency anticipates the need to revise the occupational assessments conducted in support of 

the 2006 RED since Margins of Exposure (MOE)s were calculated using assumptions that 

possibly underestimates exposure and will need to be reassessed using updated values. Uses of 

ABS that may result in occupational handler exposure are presented in Table 12.

3.3.1 Occupational Handler Exposure

Occupational and Residential Exposures were assessed in the July 2006 RED and were assessed 

in a separate occupational risk assessment (D327732). At that time in 2006, alkylbenzene 

sulfonates active ingredients were used in twenty-three registered end-use products. 

Alkylbenzene sulfonates are registered for use as sanitizers that are designated for use in 

agricultural, food handling and commercial/institutional/industrial settings (Use Site Categories 

I, II, and III respectively). ABSs are also an ingredient in certain cleaning products. However, 

alkylbenzene sulfonates are now in twelve registered pesticide products. The current use patterns 

are similar, and the application rates are either the same or lower than those presented in the 

RED. No residential use sites were identified for the active ingredient; therefore, a residential 

assessment will not be conducted. 

A dermal toxicological endpoint was not required in the RED and the agency does not anticipate 

a dermal toxicological endpoint for registration review. Thus, an occupational dermal assessment 

will not be conducted. According to the RED, ABS did not exhibit systemic or developmental 

toxicity in several dermal toxicity studies. The agency stated that workers will likely be protected 

from irritation effects based on the personal protective equipment specified on the labels. 
Page 20 of 63

Although the agency conducted an occupational inhalation risk assessment in the RED, the 

agency anticipates the need to conduct an updated occupational inhalation risk assessment for 

registration review. Based on the need to assess current application rates, reevaluation of toxicity 

data and the expected inhalation toxicity that will be received from the RED DCI, the agency 

anticipates that a new inhalation toxicological endpoint will likely be developed.

Workers can be exposed to a pesticide through mixing, loading, and/or applying a pesticide.

Occupational inhalation post-application exposures are presumed to be negligible because of the 

low vapor pressure of ABS. This is consistent with the earlier risk assessment for the RED which 

stated that “alkylbenzene sulfonates have a low vapor pressure (5.1x10-10 to 6.02x10-15 mmHg), 

so that any standing solutions that may result in post application exposure were deemed 

negligible (EPA, 2006).” 

Occupational handlers of alkylbenzene sulfonates include workers in a variety of occupational 

settings including food processing facilities and at agricultural premises. Examples of registered 

uses found on labels and outlined in the RED for ABS include application to indoor non-food 

hard surfaces (e.g. floors, walls, tables, chairs, and benches), food dispensing equipment (e.g. 

pre-mix and post-mix vending machines, conveyor belts, slicers, peelers, tanks), indoor food 

contact hard surfaces (glasses, dishes, silverware, countertops, etc.), agricultural tools, and fruits 

and vegetables (post-harvest).

EPA, 2006. Alkylbenzene Sulfonates (ABS) Preliminary Risk Assessment for the Reregistration 

Eligibility Decision (RED) Document. PC Code: 079010, 190116 and 098002. Case No. 4006.

D. Smegal/ A.Assaad/W.Dyksra. DP Barcode: D323972.

The representative scenarios selected for assessment will be evaluated using maximum 

application rates as recommended on the product labels for ABS.

Table 12 – Occupational Handler Exposure Scenarios for ABS

Scenario Exposure 

Route(s) Duration 

Occupational Exposures

Agricultural Premises and Equipment (Use Category I)

Dairy Farm Milking Equipment

Open pour for circulate-inplace (CIP) cleaning

Inhalation Short and 

Intermediate Term Wipe 

Trigger Spray

Low Pressure Spray

Food Handling/Storage Establishments Premises and Equipment (Use Site Category II)b

Hard surface sanitizers on countertops and 

floorsa

Open pour liquids and 

powders

Inhalation Short and

Intermediate Term

Wipe

Trigger Spray

Low Pressure Spray

Mopping

Restaurants/Eating Establishments b

Immersion

Inhalation Short and 

Intermediate Term Wipe

Low Pressure Spray

Food processing equipmentc (tanks, 

conveyor belts, spray systems)

Open pour liquids and 

powders for CIP Inhalation Short and 

Wipe Intermediate Term

Trigger Spray
Page 21 of 63

Low Pressure Spray

a Hard surfaces are treated in restaurants and food processing plants 

b Restaurant uses of sanitizers include washing dishes, glasses, utensils, pots and pans 

c Representative exposure scenarios that examine possible exposures when cleaning equipment found in food 

processing plants, beverage processing plants, dairy farm plants, dairy farm cheese plants, meat processing plants, 

poultry processing plants, and bottling plants.

3.3.2 Residential Exposures

Since there are no residential uses for the currently registered products, a residential assessment 

will not be conducted. 

3.4 Aggregate and Cumulative Exposure 

3.4.1 Aggregate Exposures 

EPA anticipates the need to revise the aggregate assessment conducted in support of the 2006

RED. Upon a reevaluation and selection of toxicological endpoints, combined with the human 

health exposure assessments expected as a part of this registration review case, aggregate 

exposures will need to be assessed. This assessment will include dietary exposures. 

3.4.2 Cumulative Exposures 

With respect to cumulative exposure, unlike other pesticides for which EPA has followed a 

cumulative risk approach based on a common mechanism of toxicity, EPA has not made a 

common mechanism of toxicity finding as to ABS and any other substances and ABS does not 

appear to produce a toxic metabolite produced by other substances. For the purposes of this 

registration review, therefore, EPA has not assumed that ABS has a common mechanism of 

toxicity with other substances. For information regarding EPA’s efforts to determine which 

chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such 

chemicals, see the policy statements released by EPA’s Office of Pesticide Programs at 

http://www.epa.gov/pesticides/cumulative/. 

4 Environmental Risk Assessment 

An ecological risk assessment was not conducted previously on the use patterns for ABS. It was 

determined in the 2006 RED that minimal or no environmental exposure to terrestrial or aquatic 

organisms is expected to occur due to the fact that the use patterns were considered indoors. It 

has since been recognized that such use patterns may have an additional down-the-drain 

component resulting in potential releases to wastewater treatment plants (WWTPs) and 

subsequently the environment. Such releases for the linear 12 carbon chain ABS (C12-ABS) 

actives in this case are considered highly unlikely to be discharged from WWTPs due to sorption 

and rapid biodegradation as discussed in Section 4.1. Therefore except for evaluating the 

potential hazard to WWTPs, no quantitative environmental risk assessment is planned for ABS.

4.1 Environmental Fate and Transport

Registrants have submitted studies primarily from the open literature to support uses of ABS.

The agency has also identified additional open literature studies which address fate of linear C12-

ABS or used EPI Suite version 4.1 to estimate physical parameters for the actives in this case.

The actives considered in this case are a subset of the linear alkylbenzene sulfonate (LAS) group 

and contain a C12 alkyl chain length and a sulfate group in the para or 4 position on the ring. In 
Page 22 of 63

the open literature, unless otherwise noted, the term linear alkylbenzene sulfonate (LAS) refers 

to a mixture of homologues of different alkyl chain lengths (C10-16) and isomers differing in the 

phenyl ring positions (2 to 5 phenyl). Additionally the term ABS in the open literature may 

include branch chain alkyl groups. Fate can be affected by the chain length, branching, and 

phenyl isomer configuration, so fate information specifically for the linear C12-ABS considered 

in this case is used when available rather than general information on LAS or ABS. Studies that 

were conducted by registrants include a hydrolysis study (MRID 40548801 and 40970701) and a 

soil leaching/adsorption/ desorption study (MRID 40655201 and 94032011). The following 

summary is based on a more detailed summary and review of the fate data provided in Appendix 

C.

Based on available fate data the major environmental dissipation for LAS, including linear C12-

ABS, is aerobic biodegradation (Fairchild, 1993; Larson and Payne, 1981; Temmink and 

Klapwijk, 2004). In an activated sludge pilot-scale municipal waste plant monitoring study >99%

of the LAS (C12-homologue) load was removed by aerobic biodegradation (Temmink and 

Klapwijk, 2004). Fairchild (1993) reported rapid environmental degradation of LAS homologs in 

aquatic systems with measured half-lives of <2 days. Early work by Larson and Payne (1981) on

linear ABS using water samples collected from above and below a municipal WWTP discharge 

also showed rapid degradation with a half life of 0.23 days (5.52 hours) for the alkyl chain, while 

the same study showed that the benzene ring mineralized with a half life of 0.73 days (17.52 

hours) as indicated by the amount of radiolabeled carbon dioxide collected. 

The other major determinate of fate from the available studies is adsorption to sludge, and 

soil/sediment. In the Temmink and Klapwijk (2004) pilot-plant study 92-98% of the LAS-C12 

adsorbed to sludge. Jacobsen (2004) discussed the mechanistic basis for sorption of LAS to 

soils.The sorption of LAS to soil was identified as attributable to a combination of several 

mechanisms and sorption to both the organic and inorganic fraction of the soil has been 

demonstrated. The linear alkyl group of LAS is hydrophobic and sorbs to the non-polar fractions 

of the soil, such as the organic matter. However, the sulfonate group of LAS is negatively 

charged and hydrophilic and therefore interacts with positively charged soil components or polar 

groups, such as hydroxyl-groups, minerals, or oxides.

Based on the following the antimicrobial uses of linear C12-ABS are not expected to exceed 

levels of concern in the environment for federally listed endangered and threatened species (i.e., 

listed species) or non-listed species and their critical habitat:

• Rapid aquatic biodegradation and mineralization of alkyl groups (half-life) of 5.52 hours

and the benzene ring (half-life 17.52 hours) (Larson and Payne, 1981);

• Rapid sorption to sludge (5-10 min equilibrium with >99% sorption) (Temmink and 

Klapwijk, 2004);

• Rapid biodegradation in activated sludge (half-life <2 days) ((Fairchild, 1993; Larson and 

Payne, 1981; Temmink and Klapwijk, 2004);
Page 23 of 63

• Disposal down drains would be expected to be below levels of concern given the 

production volume for antimicrobial use is on only on the order of 300,000 lbs annually, 

and use would be widely dispersed across the nation and its territories6.

4.2 Environmental Conceptual Model Exposure Pathways

Figure 1 presents the conceptual model diagram for ecological exposure and effects of 

dodecylbenzene sulfonic acids and its reaction/products/degradates from indoor food and nonfood use sanitizers. Although there is potential for this chemical and its reaction 

products/degradates to be released to wastewater treatment plants as a result of its use as indoor 

food and non-food use sanitizers, persistence in surface water of any residual amounts of this 

chemical and its reaction products/degradates that may be discharged from wastewater treatment 

plant effluents is not expected due to rapid biodegradation and sorption to sludge.

Figure 2 presents the conceptual model diagram for ecological exposure and effects of sodium 

dodecyl sulfonate and its reaction products/degradates from antimicrobial fruit and vegetable 

washes and food contact sanitizer. Although there is potential for these chemicals and their 

reaction products/degradates to be released to wastewater treatment plants as a result of their use 

fruit/vegetable washes and food contact sanitizers, persistence in surface water of any residual 

amounts of these chemicals and their reaction products/degradates that may be discharged from 

wastewater treatment plant effluents is not expected due to rapid biodegradation.

 6 For example a conservative estimate (300000 pounds annually/356 days) (453.592E3 mg/pound) ÷ (42,225E6 

gallons/day)(3.78541 liters/gallon) = 0.002 mg/L where the wastewater treatment volume of 42,225E6 is from the 

1996 U.S. Census (http://www.allcountries.org/uscensus/391_wastewater_treatment_facilities.html).
Page 24 of 63

Figure 1 – Conceptual Model for Ecological Exposure and Effects of Dodecylbenzene 

Sulfonic Acid and its Reaction Products/Degradates from Indoor Food and Non-food Use 

Sanitizers Ecological Effects Assessment

Stressor

Source

Receptors 

and Exposure 

Routes

Attribute

Change(s)

Individual organisms

Reduced survival

Reduced growth

Reduced reproduction

Food chain

Reduction in algae

Reduction in prey

Modification of PCEs related 

to prey availability

Habitat integrity

Reduction in primary productivity

Reduced cover

Community change

Modification of PCEs related to 

habitat

Aquatic Animals

Invertebrates

Vertebrates

Exposure

Media

Ingestion Ingestion

Uptake/gills 

or integument

Aquatic Plants

Non-vascular

Vascular

Uptake or sorption by 

cells, roots, leaves, 

Piscivorous*

Invertebrates

Vertebrates

Phytoplanktivore/ 

Herbivore

Invertebrates

Vertebrates

*As used here this term refers to animals (terrestrial or aquatic) that eat not just fish but any aquatic animal (e.g., amphibians, mollusks, crustaceans, etc.)

Ingestion

Waste Water Treatment Plant (WWTP)

Key

Most likely

exposure pathway 

contributing to risk

Low likelihood of 

contributing to risk

Indoor food and non-food use sanitizers

WWTP 

microorganisms

Uptake or 

sorption

Population

Respiration 

inhibition

Waste Water Disposal Down-the-Drain

Surface Water

Sediment
Page 25 of 63

Figure 2 – Conceptual Model for Ecological Exposure and Effects of Sodium Dodecyl 

Sulfonate and its Reaction Products/Degradates from Antimicrobial Fruit and Vegetable 

Washes and Food Contact Sanitizer

4.2.1 Mechanism of Action

ABS are surface-active substances and interact with the lipid-bilayer membrane of living cells in 

the same way they facilitate phase mixing and micelle formation (Singer et al., 1994).

For aquatic organisms the destabilization of cell membranes and resulting altered membrane 

permeability and lysis lead to interrupted cellular respiration and asphxyation. In a fish early lifestage study, embryo mortality was due to rupture of the embryonic membrane (Singer et al., 

1993). The agency does not anticipate the need to conduct a quantitative ecological risk 

assessment for alkylbenzene sulfonates. The registered use pattern as a food and non-food 

contact sanitizer and a fruit and vegetable wash is expected to result in minor or insignificant 

amounts reaching surface waters due to rapid biodegradation of the chemicals.

4.2.2 Measures of Effect (Ecotoxicology Endpoints)

Current selected ecotoxicological endpoints for conducting the risk assessment are provided in 

Table 13. All available ecotoxicity endpoints from studies submitted by registrants are tabulated 

separately for each alkylbenzene sulfonate in Appendix D

Stressor

Source

Receptors 

and Exposure 

Routes

Attribute

Change(s)

Individual organisms

Reduced survival

Reduced growth

Reduced reproduction

Food chain

Reduction in algae

Reduction in prey

Modification of PCEs related 

to prey availability

Habitat integrity

Reduction in primary productivity

Reduced cover

Community change

Modification of PCEs related to 

habitat

Aquatic Animals

Invertebrates

Vertebrates

Exposure

Media

Ingestion Ingestion

Uptake/gills 

or integument

Aquatic Plants

Non-vascular

Vascular

Uptake or sorption by 

cells, roots, leaves, 

Piscivorous*

Invertebrates

Vertebrates

Phytoplanktivore/ 

Herbivore

Invertebrates

Vertebrates

*As used here this term refers to animals (terrestrial or aquatic) that eat not just fish but any aquatic animal (e.g., amphibians, mollusks, crustaceans, etc.)

Ingestion

Waste Water Treatment Plant (WWTP)

Key

Most likely

exposure pathway 

contributing to risk

Low likelihood of 

contributing to risk

Antimicrobials Fruit and Vegetable Washes and Food Contact Sanitizer

WWTP 

microorganisms

Uptake or 

sorption

Population

Respiration 

inhibition

Waste Water Disposal Down-the-Drain

Surface Water

Sediment
Page 26 of 63

Table 13 – Existing Effects Endpoints for Risk Assessment of ABS

Receptor 

Group Test Material Surrogate Species Risk Scenario

Toxicity 

Endpoint Reference

Avian LAS 87.6%

Northern Bobwhite 

(Colinus 

virginianus)

Acute LC50 > 1382 

mg/L (LAS)

41143901 

Supplemental

Freshwater 

Fish

Sodium alkylbenzene sulfonate 

(ABS) 70%, Sodium 

laurylbenzene sulfonate (LAS) 

65%

Rainbow Trout 

(Oncorhyncus

mykiss)

Acute

96-h LC50 =

1.68 mg/L 

(LAS) 44260009 

96 Supplemental -h LC50 = 

10.8 mg/L 

(ABS)

LAS 14%

Fathead Minnow 

(Oncorhynchus 

mykiss)

Acute 96-h LC50 = 

3.4 mg/L

44260002 

Supplemental

Benzenesulfonic acid, C10-13-

alkyl derivatives (85536-14-7)

as a surrogate for benzene 

sulfonic acid, C10-16-alkyl 

derivatives (190116)

Carp (Cyprinus 

carpio) Acute 96-h LC50 = 

5.6 mg/L

HPV cited Kurtin 

1997; OECD 1984

(reliability: 1 - valid 

without restriction)7

n-dodecylbenzene sulfonate as a 

surrogate for dodecylbenzene 

sulfonic acid (098002)

Ide (Leuciscus 

idus) Acute 96-h LC50 = 

4.1 mg/L

HPV cited Knie et 

al. 1983 (reliability: 

1 – valid without 

restriction)8

 7 Only studies with the highest level of reliability were listed in this table. The Klimisch et al. (1997) scoring system 

is used to categorize the reliability of HPV studies as follows: 

1 = reliable without restrictions: “studies or data...generated according to generally valid and/or internationally 

accepted testing guidelines (preferably performed according to GLP) or in which the test parameters documented are 

based on a specific (national) testing guideline...or in which all parameters described are closely related/comparable 

to a guideline method.” 

2 = reliable with restrictions: “studies or data...(mostly not performed according to GLP), in which the test 

parameters documented do not totally comply with the specific testing guideline, but are sufficient to accept the data 

or in which investigations are described which cannot be subsumed under a testing guideline, but which are 

nevertheless well documented and scientifically acceptable.” 

3 = not reliable: “studies or data...in which there were interferences between the measuring system and the test 

substance or in which organisms/test systems were used which are not relevant in relation to the exposure (e.g., 

unphysiologic pathways of application) or which were carried out or generated according to a method which is not 

acceptable, the documentation of which is not sufficient for assessment and which is not convincing for an expert 

judgment.” 

4 = not assignable: “studies or data....which do not give sufficient experimental details and which are only listed in 

short abstracts or secondary literature (books, reviews, etc.). 8 Ibid.
Page 27 of 63

Receptor 

Group Test Material Surrogate Species Risk Scenario

Toxicity 

Endpoint Reference

Freshwater 

Invertebrates

LAS 65.0% C11, C12 Waterflea (Daphnia 

magna) Acute

EC50:

LAS-C10 = 

29.5 mg/L

LAS-C12 = 

6.84 mg/L

LAS-C14 = 

0.80 mg/L

LAS-C16 = 

0.20 mg/L

47025025

Supplemental

Benzenesulfonic acid, C10-13-

alkyl derivatives (85536-14-7) 

as a surrogate for benzene 

sulfonic acid, C10-16-alkyl 

derivatives (190116)

Waterflea (Daphnia 

magna) Acute 48-h EC50 = 

5.2 mg/L

Kurtin 1997; OECD 

1984

(reliability: 1 - valid 

without restriction)

Dobanic acid (linear alkyl 

benzenesulfonic acid, C10-13) 

as a surrogate for benzene 

sulfonic acid, C10-16-alkyl 

derivatives (190116)

Waterflea (Daphnia 

magna) Acute 48-h EC50 = 

2.9 mg/L

HPV Cited 

Stephenson 1981 

(reliability: 1 – valid 

without restriction)

n-dodecylbenzene sulfonate as a 

surrogate for dodecylbenzene 

sulfonic acid (098002)

Waterflea (Daphnia 

magna) Acute 24-h EC50 = 

12 mg/L

HPV cited Knie et 

al. 1983 (reliability: 

1 – valid without 

restriction)

Aquatic 

Plants

LAS Algae (Selenastrum 

capricornutum)

96-h EC50 =

70.27 mg/L

42439803 

Supplemental

Benzenesulfonic acid, C10-13-

alkyl derivatives (85536-14-7) 

as a surrogate for benzene 

sulfonic acid, C10-16-alkyl 

derivatives (190116)

Algae 

(Scenedesmus 

subspicatus)

72-h EC50 = 

36 mg/L

HPV cited Kurtin 

1994; OECD 1984

(reliability: 1 – valid 

without restriction)

Dobanic acid (linear alkyl 

benzenesulfonic acid, C10-13) 

as a surrogate for benzene 

sulfonic acid, C10-16-alkyl 

derivatives (190116)

Algae (Selenastrum 

capricornutum)

96-h EC50 = 

170 mg/L

HPV cited 

Stephenson 1981

(reliability: 1 – valid 

without restriction)

n-dodecylbenzene sulfonate as a 

surrogate for dodecylbenzene 

sulfonic acid (098002)

Algae 

(Haematococcus 

pluvialis)

96-h EC50 = 

50 mg/L

HPV cited Knie et 

al. 1983 (reliability: 

1 – valid without 

restriction)

4.3 Exposure Analysis Plan

4.3.1 Aquatic and Terrestrial Wildlife Exposure Estimates

Although there is potential for dodecylbenzene sulfonic acids and their reaction 

products/degradates to be released to wastewater treatment plants as a result of their use as 

indoor food and non-food use sanitizers and for sodium dodecyl sulfonate and its reaction 

products/degradates to be released to wastewater treatment plants as a result of use in 
Page 28 of 63

fruit/vegetable washes and food contact sanitizers, these uses are not expected to result in 

exceedance of exposures of concern based on the following factors;

• Rapid sorption to sludge (5-10 min equilibrium with >99% sorption) (Temmink and 

Klapwijk, 2004) which will remove ABS from the water column;

• Rapid biodegradation in activated sludge (half-life <2 days) ((Fairchild, 1993; Larson and 

Payne, 1981; Temmink and Klapwijk, 2004);

• Rapid aquatic biodegradation and mineralization of alkyl groups (half-life) of 5.52 hours

and the benzene ring (half-life 17.52 hours) (Larson and Payne, 1981); and 

• Down the drain loads would be expected to be below levels of concern given the 

production volume for antimicrobial use is only on the order of 300,000 lbs annually, use 

would be widely dispersed across the nation and its territories, and there would be 

dilution and time for degradation to occur before reaching any WWTP9.

Exceedance of levels of concern is expected to be highly unlikely for terrestrial organisms given 

the following factors:

• The only potential route of exposure for terrestrial organisms is from the aquatic 

exposure route as uses are indoors;

• ABS from antimicrobial uses are not expected to reach the aquatic environment or reach 

it in significant quantities as discussed in the preceding paragraph;

• Exposure via the food web is highly unlikely given the low bioconcentration potential 

(BCFs <1000 see Appendix C), and the lack of significant quantities reaching the aquatic 

environment. .

4.3.2 Human Health Drinking Water Exposure Estimates

As discussed in Section 4.1 and Appendix C, based on environmental fate data, drinking water 

concentrations are expected to be limited because of lack of persistence in environmental media 

and sorption to soil and sediment. Therefore additional data and a drinking water assessment are 

not considered to be necessary at this time. 

4.4 Effects Analysis Plan

There are no effects data gaps for ABS.

4.5 Endangered Species Determination

Based on the ABS use patterns, their ready biodegradability, and low toxicity, the Agency 

anticipates the registered uses will have “no effect” on endangered or threatened terrestrial or 

aquatic species, or their designated critical habitats, as listed by the USFWS and the NOAA.

However, the Agency will review any comments made by the public on this document and will 

conduct an environmental risk assessment if new information warrants such action. An 

ecological risk assessment planned during registration review allows the Agency to determine 

whether an antimicrobial pesticide’s use has “no effect” or “may affect” federally listed 

threatened or endangered species (listed species) or their designated critical habitats. When an 

assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical 

 9 For example a conservative estimate (300000 pounds annually/356 days) (453.592E3 mg/pound) ÷ (42,225E6 

gallons/day)(3.78541 liters/gallon) = 0.002 mg/L where the wastewater treatment volume of 42,225E6 is from the 

1996 U.S. Census (http://www.allcountries.org/uscensus/391_wastewater_treatment_facilities.html).
Page 29 of 63

habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine 

Fisheries Service (the Services), as appropriate.

5 Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its 2006 reregistration decision for ABS, EPA reviewed these data 

and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing 

hazard database. However, as required by FFDCA section 408(p), ABS is subject to the 

endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 

2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 

which contains 58 pesticide active ingredients and 9 inert ingredients. ABS is not among the 

group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. 

Accordingly, as part of registration review, EPA will issue future EDSP orders/data call-ins, 

requiring the submission of EDSP screening assays for ABS.

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website: http://www.epa.gov/endo/. 

6 Optional Label Changes 

It is recommended that the labels for all four EPA registrations for fruit and vegetable washes be 

updated to reflect application rates (ppm on an active ingredient basis). This information is 

necessary in order to conduct a dietary assessment of the fruit and vegetable wash use pattern.
Page 30 of 63

7 Next Steps

A DCI will be developed regarding the data needs listed under Table 9 “Studies Anticipated as 

Needed for the Registration Review of ABS” of this document. The agency expects to issue the 

DCI in September 2014.
Page 31 of 63

8 References 

Barid, Colin. Environmental Chemistry, 2nd Edition. W.H. Freeman and Company: New York, 2003.

Cavalli, L., et. al. (1993). “LAS Removal and Biodegradation in a Wastewater Treatment Plant.” 

Environmental Toxicology and Chemistry. Vol. 12. pp 1777-1788.

EPA (U.S. Environmental Protection Agency). 2006. Assessment Plan for the Linear Alkylbenzene 

(LAB) Sulfonic Acids Category in Accordance with the USEPA High Production Volume 

Chemical Challenge Program. EPA 201-14485A. Office of Pollution Prevention and Toxics, U.S. 

Environmental Protection agency, Washington, DC. May 20, 2003 [online]. Available: 

http://www.epa.gov/HPV/pubs/summaries/linalkbz/c14485tp.pdf [accessed Nov. 20, 2012].

EPA (U.S. Environmental Protection Agency). 2006. An AD Memo from Talia Milano to Heather Garvie

on “Environmental Fate Assessment of Alkylbenzene Sulfonates for the Registration Eligibility 

Decision (RED), July, 2006.”

EPA (U.S. Environmental Protection Agency). 2006. An AD Memo from Richard Petrie to Jennifer 

Slotnick on “Ecological Hazard and Environmental Risk Assessment of alkylbenzene sulfonates 

for Regitration Eligiblity Document (RED), January, 2006.”

EPA (U.S. Environmental Protection Agency). 2006. AD Memo from Robert Quick to Heather Garvie on 

“Dietary risk assessment for alkylbenzene sulfonates, March, 2006.”

EPA (U.S. Environmental Protection Agency). 2006. Reregistration Eligibility Decision for Alkylbenzene 

Sulfonates.

European Oilfield Speciality Chemicals Association. 2000. Summary Report Surfactant 

Bioaccumulation Review Project. 106 pp. http://www.eosca.eu/wpcontent/uploads/Surfactants-Report.pdf

Fairchild,James F, et. al. (1993). Evaluation of a Laboratory-Generated OEC For Linear Alkylbenzene

Sulfonate in Outdoor Experimental Streams. Environmental Toxicology and Chemistry. Vol. 12.

pp 1763-1776.

Federle TW and NR Itrich (1997), Comprehensive approach for assessing the kinetics of primary 

and ultimate biodegradation of chemicals in activated sludge: application to LAS, 

Environ. Sci. Technol. 31: 1178-1184.

FDA (U.S. Food and Drug Administration). “Sanitizing Solutions: Chemistry Guidelines for Food 

Additive Petitions”. Version 1.1; January 1993.Geneva, 1996 

http://inchem.org/documents/ehc/ehc/ehc169.htm.

Huddleston,RL, and Allred, RC. 1963. Microbial oxidation of sulfonated alkylbenzenes. 

Dev.Ind. Microbiol., vol.4, pp24-38

International Programme on Chemical Safety, Environmental Health Criteria 169, Linear Alkylbenzene

Sulfonates and Related Compounds. World Health Organization.

Jacobsen, Anne Marie, Gerda Krog Mortensen, and Hans Christian Bruun Hansen. (2004). “Degradation

and Mobility of Linear Alkylbenzene Sulfonate and Nonylphenol in Sludge- Amended Soil.”

Journal of Environmental Quality. Vol 33. pp. 232-240.

Kuhnt, Gerald. (1993). “Behavior and Fate of Surfactants in Soil.” Environmental Toxicology and

Chemistry. Vol. 12. pp 1813-1820.

Kwok, T.K. 2011. Assessing the effect of surfactants on activated sludge processes using 

sequencing batch reactors. Master’s Thesis Environmental Engineering, School of Civil, 

Environmental and Chemical Engineering, RMIT University. 111 pp. 

http://researchbank.rmit.edu.au/eserv/rmit:11997/Kwok.pdf

Larson, RJ, and Payne, AG. 1981. Fate of the Benzene Ring of Linear Alkylbenzene Sulfonate in 

Natural Waters. Applied Environ. Microbiol., vol. 41(3), pp 621-627

Painter, H. A. (1986) Testing the toxicity of chemicals by the inhibition of respiration of 

activated sludge. Toxicity Assessment 1:515-524.
Page 32 of 63

Swisher, RD, 1987. Surfactant Biodegradation, second edition, Surfactant Science Series Vol.18, 

Marcel Dekker, Inc. New York, NY

Schoerl, P, 1989. Basic Principles of LAS Biodegradation, Tenside Surfactant Detergents, 26, pp 

86-94.

The Estimation Programs Interface (EPI) Suite. Windows based suite of physical/chemical properties and

environmental estimation models developed by the US EPA’s Office of Prevention, Pesticides,

and Toxic Substances (OPPTS) and Syracuse Research Institute (SRC). 

http://www.epa.gov/opptintr/exposure/docs/EPISuitedl.htm

Temmink, H.and B. Klapwijk. 2004. Fate of linear alkylbenzene sulfonate (LAS) in activated 

sludge plants. Water Research 38:903-912.

Singer MM, George S, Jacobson S, Lee I, Tjeerdema RS, Sowby ML (1993) Comparative toxicity of two 

oil dispersants to the early life stages of two marine species. Environ Toxicol Chem 12:1855-

1863.

Singer MM, George S, Jacobson S, Lee I, Tjeerdema RS, Sowby ML (1994) Comparative effects of oil 

dispersants to the early life stages of topsmelt (Atherinops affinis) and kelp (Macrocystis 

pyrifera). Environ Toxicol Chem 13:649-655
Page 33 of 63

Appendix A Toxicology Profile

Acute Toxicity for Product Labeling 

Table 14 – Acute Toxicity Studies for ABS

Guideline/Study Type MRID No. Results Toxicity Category

870.110 Acute oral Multiple LD50 = range from 404 to over 5000 mg/kg III - IV

870.1200 Acute Dermal 94032006 LC50 = 1200 mg/kg II

870.1300 Acute Inhalation 003442* LC50 = 200 mg/L IV

870.2400 Acute Eye 003444* I

870.2600 Dermal irritation 003444* Severe Irritation at 72 hours II

870.2600 Skin Sensitization Open literature+ Weak to moderate sensitization ---

* Tox record No.

+ Nusair, T.L. (1988) Consumer Products: Risk Assessment process for Contact Sensitization, 

Toxicologist 8:258. (HERA)

Subchronic Toxicity 

Adequacy of data base for subchronic toxicity: The data base for subchronic toxicity is

considered complete. No additional studies are expected to be required at this time. The major 

reviews by the WHO (1996), and HERA (2004) report and/or summarize many subchronic 

studies via the oral (gavage, feed, and drinking water), dermal, and inhalation routes. Only the 

critical studies or ones for which OPP has developed DERs over the years are summarized here.

870.3100 90-Day Oral Toxicity – Rat

LAS was administered for 2, 4, and 12 weeks to male rats (5/group) at a single dose of 1.5% in

the diet (750 mg/kg bw/day). LAS suppressed body weight gain, and the relative liver weight

was increased after 2 weeks of LAS administration. Serum biochemical examinations revealed

significant increases in ALP and GTP at each observation period and significant decreases in

cholesterol and protein in 4 weeks. Enzymatic examinations of the liver revealed decreases in

G6Pase and G6PDH and an increase in isocitrate dehydrogenase (IDH) at each observation

period. Enzymatic examinations of the renal cortex revealed decreases in G6Pase and 5'-

nucleotidase at each observation period, an increase in LDH at 12 weeks, and an increase in IDH

at 2 and 4 weeks. Enzymatic examinations in the renal medulla revealed a decrease in Na, 

ATPase, and an increase in LDH at 12 weeks, a decrease in IDH at 2 weeks, and an increase in

IDH at 12 weeks (Ikawa et al.1978; as cited in HERA, 2004).

In another study (MRID No. 43498412; Kay et al. (1965) as cited in HERA, 2004), LAS (87.9%

purity) was administered in the diet at dietary levels of 0, 200, 1000, and 5000 ppm for 90 days

to weanling Sprague-Dawley Rat (10/sex/dose).

Body weight and food consumption was measured pretest and weekly on all animals and

hematology and urine analysis were done on 5/sex/group at days 0, 30, 60, and 90. Clinical

chemistry measurements were not performed. All animals were sacrificed by ether inhalation and

subject to gross necropsy. Weights of liver, kidneys, spleen, gonads, heart and brain were taken

and absolute and relative (both body and brain) organ weights were calculated. Histopathology

was performed on 5/sex from control and high dose and 3/sex from low and mid dose animals
Page 34 of 63

from 25 organs and tissues. Required tissues not examined were aorta, eyes, cecum, skin,

trachea, sciatic nerve, esophagus, rectum, thymus, mammary gland, epididymis, spinal cord, and

salivary glands. Two low dose males died early in the study from respiratory illness There was

no compound-related effects in body weight, food consumption, hematology, urine analysis,

organ weight, and histopathology.

Core Classification:ACCEPTABLE/Guideline.

870.3150 90-Day Oral Toxicity – Monkey, MRID 43498413

Groups of 3 male and 3 female Rhesus monkeys 18-36 months old and weighing 2.0-4.4 kg,

were treated simultaneously with SDDBS (LAS) in distilled water at doses of 0 (controls), 30

mg/kg (oral) + 0.3. mg/kg (subcutaneous), 150 mg/kg (oral) + 0.5 mg/kg (subcutaneous) and 300

mg/kg (oral) + 1 mg/mg (subcutaneous) for 28 days (MRID 43498413). Parameters measured

were body weight, ophthalmoscopy, hematology, clinical chemistries, urinalysis, necropsy,

organ weights, and histopathology. NOEL is 30 mg/kg (p0) + 0.1mg/kg (sc). Effects seen in the

high dose were emesis (vomiting) and liquid feces. Liquid feces were also seen in the mid dose.

All treated animals had fibrosis at the subcutaneous injection site, but this was not included in

the determination of a NOEL. Both oral and subcutaneous administration of the chemical are 

used in this study.

Core Classificataion Not Acceptable/non-guideline. Both oral and subcutaneous 

administration of the test substance were administered simultaneously.

870.3200 21/28-Day Dermal Toxicity – Rat

Mathur et al. (1992). J Toxicol Cutan Ocular Toxicol, 11(1): 3-13 (as cited in WHO 1996). A 

solution of LAS in distilled water equivalent to 60 mg/kg bw was applied to a 4-cm2 area of

clipped dorsal skin daily of 12 Guinea Pigs for 30 days. The activities of β-glucuronidase,

gamma- glutamyl transpeptidase, 5-nucleotidase, and sorbitol dehydrogenase were increased in

liver and kidney. Lipid peroxidation was increased in the kidney but not in liver, and the

glutathione content was unchanged in both organs. Extensive fatty changes were found in hepatic 

lobules, with dilation of sinusoids; tubular lesions were found in the kidney, predominantly in the 

proximal and distal portions.

Core Classification: ACCEPTABLE

870.3465 90 Day Inhalation Toxicity; MRID 43498403

In a subchronic inhalation toxicity study in monkeys (MRID 43498403), groups of 5 male and 4

female cynomolgous monkeys, 1.6 to 3.7 kg, were randomly divided into 12 nominal groups

(mg/m3) - control, detergent (D), enzyme (E), or both at levels at 0, l00(D) and 0.001(E), 0.01(E), 

0.1(E) and 1(E)) together with [ 0, 1(D), 10(D), and 100(D)] for 6 hours daily, 5 days a week for 

6 month. Particle analysis and gravimetric determinations showed particle size to have a MMD 

and gravimetric concentrations to be slightly higher than nominal. The detergent formulation 

contained 13% C12 linear alkylbenzene sulfonate (the remaining major ingredients were sodium 

tripolyphosphate [39%]; sodium sulfate [40%]; and sodium silicate [7%]).

Core Classification: UNACCEPTABLE/nonguideline

The inhalation study upon further review was found unacceptable because the formulation used 

13% alkylbenzene sulfonate in addition to the presence of enzymes. The sponsor submitted a 
Page 35 of 63

waiver was then denied. Therefore, a 90-day nose only rat inhalation study using DDBSA 

(Guideline 870.3465) is expected to be required (Tao, J. memo, 2/7/12).

Developmental Toxicity 

Adequacy of data base for Prenatal Developmental Toxicity: The data base for prenatal 

developmental toxicity is considered complete. There are many developmental studies that have 

been identified and reviewed in the WHO and HERA documents. No additional studies are 

expected to be required at this time.

870.3700a Prenatal Developmental Toxicity Study – Rat

Teratology - rat, mouse, rabbit, MRID 43498426 (“Palmer Part I”).

Randomized groups of 20 CD-1 pregnant mice, 20 CD rats, and 13 NZW rabbits were housed

individually and fed appropriate diets ad libitum. Day 0 of gestation was judged by a vaginal

plug in rats and mice and coitus in rabbits. Dosing began on day 6 and continued daily up to day

15 for mice and rats and day 18 for rabbits. The test material was supplied by Lion fat and Oil

Co., Led, Tokyo. Doses were 0, 0.2, 2.0, 300 and 600 mg/kg BW. Animals were observed daily

and weighed regularly. At termination (Days 17, 20, and 29 for mice, rats, and rabbits), the uteri

were immediately dissected and contents examined to determine implantations, viable young,

embryonic deaths (abortion or resorption sites). Ovaries were examined and the number of

corpora lutea counted for rats and rabbits. Fetuses were weighed and externally examined for

abnormalities. With rabbits, the fetuses were immediately dissected and examined for visceral

abnormalities. Sex was determined by gonadal inspection and carcasses preserved in alcohol for

subsequent clearing, staining with alizarin, and skeletal examination. With mice and rats,

following weighing and external examination, one third were fixed in Baum’s solution for free 

hand sectioning for visceral abnormalities and the remaining two-thirds fixed in alcohol, cleared, 

stained with alizarin and examined skeletally.

In assessing results, group means were calculated from the individual litter data in two ways.

Mean A: includes all surviving animals showing evidence of implantation, including those with

12 of 42 total litter loss. Mean B: includes only animals bearing viable young at termination. 

Mean B has more meaning when only the occasional animal shows total litter loss and Mean A 

provides a better index when several animals show total litter loss.

Generally, maternal toxicity ranked rabbits > mice > rats. In all species tested, toxic reactions

involved a disturbance of the gastrointestinal tract. Affected rabbits showed diarrhea, anorexia,

weight loss and cachexia prior to death. Total litter loss (abortion and/or total resorptions) tended

to occur as a result of maternal toxicity. The NOEL for maternal effects is 2.0 mg/kg for rabbits

and mice, and 300mg/kg for rats. At doses at or below the NOEL, values for litter size and fetal

loss were comparable to controls.

The NOEL for developmental toxicity is 2.0 mg/kg/day in mice, 300 mg/kg/day in rats, and

2.0mg/kg/day in rabbits. Although the identity of the malformations and anomalies was not

specified in the report, there was no apparent increase in numbers of malformation at any dose in

mice, rats and rabbits. Additionally, mice at the maternally toxic dose of 300 mg/kg/day had

increases in the percent of minor visceral and skeletal anomalies. Similarly, in rats, at the

maternally toxic dose of 600 mg/kg/day, there was an increase in minor visceral anomalies.
Page 36 of 63

Core Classification: ACCEPTABLE

Dermal Developmental Toxicity — Rat, Rabbit, Mouse MRID: 43511403. (Palmer Part III).

The surfactant linear alkylbenzene Sulfonate (LAS) was examined for embryotoxic and

teratogenic potential following percutaneous administration (MRID 43511403). Solutions

containing, 0.03, 0.3 or 3% LAS were applied to shaved skin during pregnancy days 2-13 in

mice, 2-15 in rats and 1-16 in rabbits. Dosages employed were 0.5 mg/rat or mouse/day and 10

mg/rabbit/day. For comparison, further groups of rats and mice were similarly treated with

concentrations of 0.3, 3 and 30% of a standard soap solution.

Marked local skin reaction, irritability, weight loss and failure to maintain or establish pregnancy

was evident in mice treated with LAS 3% soap, 3 or 30%: marked local reaction and weight loss

also occurred in rabbits receiving LAS 3%. Moderate maternal toxicity was observed among

mice treated with LAS, 0.3% and mild maternal toxicity in rats receiving LAS 3% or soap 30%

and rabbits receiving LAS 0.3%.

Effects on litter parameters were generally restricted to dosages causing marked maternal

toxicity in mice, the principal effects being higher fetal loss (with consequent reduction in viable

litter size) arising from an increased incidence of total litter losses. Although LAS at 3% was

considered to show marked maternal toxicity in the rabbit, the slightly higher fetal loss and lower

litter size did not differ significantly from control values.

The moderate maternal toxicity of LAS, 0.3% in the mouse correlated with a higher incidence of

embryonic deaths and lower litter size but only the former differed significantly from the

corresponding control value.

The incidences of major malformations, minor visceral or skeletal anomalies, and skeletal

variants provided no conclusive evidence of specific teratogenicity even at maternally toxic

dosages.

The LOEL for maternal toxicity was 0.3% (50.0 mg/kg/day), 3.0% (60.0 mg/kg/day) and 0.3%

(9.0 mg/kg/day) LAS in mice, rats and rabbits, respectively. The NOEL for maternal toxicity was

0.03% (5.0 mg/kg/day): 0.3% (6.0 mg/kg/day) and 0.03% (0.9 mg/kg/day) LAS in mice, rats and

rabbits, respectively. The LOEL for developmental toxicity was 0.3% (50.0 mg/kg/day), 3.0%

(60.0 mg/kg/day) and 3.0% (90.0 mg/kg/day), respectively. The NOEL for developmental

toxicity was 0.03% (5.0 mg/kg/day), 0.3% (6.0 mg/kg/day) and 0.3% (9.0 mg/kg/day),

respectively.

Core Classification: The study is supplementary and satisfies the guideline requirement for a 

series 83-3 developmental (dermal) toxicity study.

Mouse-Developmental

In a mouse developmental toxicity study (MRID 43498424 & 43498425), virgin female ICR/Jc1

mice, 9-10 weeks old, and weighing 30-32 grams, were used. Mice were maintained on mouse

diet CA-1 and tap water ad libitum. The mice were exposed to light to induce ovulation and were

mated with breeder males. The presence of a vaginal plug indicated day 0. On day 0, the

mother’s hair was plucked from a 2 x 3 cm area of the dorso- thoracic skin and 0.1 ml of 20%
Page 37 of 63

aqueous LAS was applied to the skin twice a day from day 0 to day 3. The mice were sacrificed

on day 3 and oviducts and uterus removed.

Embryos were flushed from the oviducts and uterus with Whitten medium. After examination,

the embryos were then. cultivated at 37oC in medium equilibrated with a 5% carbon dioxide, 5%

oxygen, and 90% nitrogen gas mixture.

A 2.0% dermally applied dose of LAS retarded development and interrupted cleavage of eggs.

Significantly higher numbers of embryos were found to be deformed in the LAS group in

comparison to controls, and most of these embryos were in the morula stage, whereas they were

mostly in the late blastocyst stage in controls.

Core Classification: ACCEPTABLE

Reproductive Toxicity

Adequacy of data base for Reproductive Toxicity: The data base for reproductive toxicity is

considered complete. No additional studies are expected to be required at this time.

870.3800 Reproduction and Fertility Effects – Rat; MRID 43498416

In a reproduction study with rats (MRID 43498416), randomized groups of 20/sex/dose weanling

Charles River CD rats (the P0 parental animals) were fed test diets containing 0, 0.02, 0.1, and

0.5% LAS (equivalent to 0, 10, 50, and 250 mg/kg/day) for 84 days (at which time they were 107

- 112 days old). Rats from each dose group were mated (1:1), litters allowed to be delivered,

pups counted (F1a), and examined, culled to 8/litter on day 4, and sacrificed at day 21 of

lactation. Pups of the F1a and F2a litters were both sacrificed after day 21 of lactation. Ten days

later, the rats were again mated to produce the F1b litters. 20/sex/dose of F1b weanlings were

selected to generate the P1 and P2 parental animals for generating the F2a, F2b, F3a and F3b litters.

Food consumption, body weight, and food efficiency were recorded weekly for the first 8 weeks.

Five male and 5 female rats from the F1b and F2b parental groups and F3b pups were selected for

necropsy. Body weight, organ weights, hematology, and histology were performed.

General reproduction including fertility, gestation, parturition, neonatal viability, lactation, and

post-weanling growth were comparable for control and test groups and no gross abnormalities

were found. There were comparable results in body weight, food consumption, hematology and

organ weight findings between control and treated animals. The only significant finding in

hematology, was in the 0.5% F2b females, whose RBCs count was depressed significantly

(15.4%) but was within the range of historical control data. The only histologic lesion of possible

significance, for which the data were not presented, was a pancreatic lesion seen in F2b males.

This lesion usually consisted of acinar atrophy and degeneration accompanied by a fibrous tissue

replacement. There were also indications of mild islet cell hyperplasia. There appeared to be an

increased incidence of the general lesion in animals fed 0.5% LAS.

The NOEL is 0.1% or 1000 ppm for reproductive toxicity and 5000 ppm (HDT) for systemic

toxicity. Based on the reported findings, the LEL is considered to be 0.5%. due to
Page 38 of 63

histopathology, hematology, and the occasional slightly decreased day 21 body weights in

female pups.

Core Classification: ACCEPTABLE

Chronic Toxicity 

Adequacy of data base for chronic toxicity: The data base for chronic toxicity is considered

complete. No additional studies are expected to be required at this time.

ABS was administered to male/female rats for 9 months in drinking water, at doses of 0.07%, 

0.2% and 0.6% (85, 145, 430 mg/kg bw/day) (Yoneyama et al.,1976 as cited in HERA, 2004).

Control groups were used. Hematological examination revealed no significant changes in any

experimental group and no organ weight changes were observed. Body weight gain was

suppressed in the males of the highest dose group and also serum-biochemical and enzymatic

parameters of the liver and kidney were affected. A significant decrease in renal Na, K-ATPase

was seen in the group given 145 mg/kg bw/day of LAS. The NOAEL is 85 mg/kg bw/day and

the LOAEL is 145 mg/kg bw/day.

Groups of 8 or 9 male/females mice were given diets containing LAS at concentrations of 0.6

and 1.8% (corresponding to 500 and 1000 mg/kg bw/day) or drinking water containing LAS at

concentrations of 0.07%, 0.2% and 0.6% for 9 months (corresponding to 100, 250, 600 mg/kg

bw/day for males and to 100, 250, 900 mg/kg bw/day for females) (Yoneyama et al., 1976 as

cited in HERA, 2004). Control groups were used.

In the mice given 500 mg/kg bw/day via the food, body weight gain was not suppressed, but the

weight of the liver increased in male and female mice. Enzymatic examinations revealed

significant decreases in LDH of the liver and in acid phosphatase of the kidneys in the male

mice. Thus, there was no NOAEL in this study since these effects were seen at the lowest dose of

500 mg/kg/day.

In the drinking water study, body weight was depressed at the highest dose for male and females,

increase in liver weight in females and significant decreases in renal Na, K-ATPase resulted in a

LOAEL of 600 mg/kg/d (males) and 900 mg/kg/d (females) with a NOAEL of 250 mg/kg

bw/day.

In a third study by the same authors (Yoneyama et al., 1972 as cited in HERA, 2004), 10 

rats/sex/dose were given the following doses of LAS in feed: 0, 0.07%, 0.2%, 0.6%, and 1.8% 

(equivalent to 0, 40, 115, 340, and 1030 mg/kg/d). The following effects were observed: diarrhea 

(high dose group only), suppressed growth (340 and 1030 mg/kg/d dose groups), increases 

cecum weight (all dose groups above 40 mg/kg/d), and renal tubular degeneration (all dose 

groups above 40 mg/kg/d). Thus, the NOAEL is 40 mg/kg/d with a LOAEL of 115 mg/kg/d for 

increased cecum weight and slight degeneration of renal tubules.
Page 39 of 63

Carcinogenicity 

Adequacy of data base for Carcinogenicity: The data base for carcinogenicity is considered 

complete. No additional studies are expected to be required at this time. 

870.4200a Carcinogenicity Study – rat; MRIDs: 43498420 and 43498419

Takahasi (MRID 43498420) performed an experiment to assess the ability of SDDBS to affect 

the induction of gastric tumors by 4-NQO (4-Nitroquinoline-1-Oxide) in male Wistar rats. Sixtyfour male rats of the Motoyania strain and 97 male Wistar rats were used in the study under the 

following regimen:

Group I (79 rats): 1 mg 4-NQO and 80 mg SDDBS (sodium dodecylbenzene sulfonate) 2-3 times 

per week for 18 weeks

Group 1’ (17 rats): same as Group I, but fasted 12 hours prior to dosing

Group II (37 rats): 4-NQO only as per Group ‘1

Group III (28 rats): SDDBS only as per Group I 

The experiment lasted 560 days and all rats dying on study or terminally sacrificed, were 

necropsied and examined histologically for gastrointestinal tumors. In Groups I and I‘, the 

presence of SDDBS- shifts the incidence of benign papillomas to malignant papillomas of the 

forestomach and the incidence of adenocarcinoma and sarcoma of the stomach were increased in 

comparison to Group II with only 4- NQO. The administration of SDDBS by itself has no effect. 

on gastric tumors (Group III). The study authors concluded .that the increased carcinogenicity 

produced by SDDBS was due to the better uptake of 4-NQO via LAS’S surfactive/detersive 

effects on the protective mucous barrier which is normally found in the glandular stomach and 

other gastric compartments of the rat. The effect of SDDBS was physical rather than chemical in 

promoting the increased tumorigenicity.

In a similar study by the same investigators, (Takahasi, MRID 43498419) Motoyama male rats 

were divided into three groups and gavaged with the following regimen;

Group I (37 rats): 1 mg 4-NQO + 80 mg SDDBS + 20 mg ethanol in a 1 ml gavage for 18 weeks.

Group II (13 rats): 4-NQO and ethanol for 18 weeks. 

Group III (13 rats): SDDBS + ethanol for 18 weeks.

Again, the experiment lasted 560 days and all rats, dying on study or terminally sacrificed, were 

necropsied and examined histologically for gastrointestinal tumors.

Survival: Mortality was 59% in Group I, 31% in Group II and 23% in Group III.

Tumors:

Group III - no gastric tumors 

Group II - 9 benign papillomas of forestomach

Group 1 - 8 benign papillomas of forestomach, 2 malignant papillomas of forestomach, 1 

hemangiosarcoma of forestomach. In glandular stomach, 2 adenocarcinomas, 1 
Page 40 of 63

hemangiosarcoma, 1 hemangioma, 5 squamous cell carcinomas and 2 rats exhibited atrophic 

gastritis.

The increased toxicity in Group I produced increased mortality and increased numbers of 

malignant tumors. The role of SDDBS in the tumorigenesis of 4 NQO was to promote increased 

absorption o 4 NQO through the forestomach and glandular stomach. 

Core Classification: ACCEPTABLE/Non-guideline

Carcinogenicity Study – rat; MRID No. 43498416

Randomized groups of 50/sex/group weanling Charles River CD rats were fed diets for 24 

months containing 0, 0.02, 0.1 and 0.5% LAS (200, 1000, and 5000 ppm, estimated to be 10, 50, 

and 250 mg/kg/day). Animals were housed individually and observed daily. Body -weight and 

food consumption was measured weekly for 12 weeks then- monthly. Interim sacrifices were 

performed on 5/sex/group at B and 15 months. Hematology was performed (RBCs, differential, 

WBC, hematocrit). Tail blood was collected from 5/sex/group for hematology at 4, 11, 15, and 

21 months. All animals killed at interim sacrifice, died on study, or terminally sacrificed were 

necropsied and representative tissues were fixed in 10% Bouin and processed for H & E. The 

following tissues were examined: liver, kidney, thyroid, trachea, esophagus, lungs, heart, spleen, 

pancreas, adrenal, stomach, small-intestine, urinary bladder, gonads, mesenteric lymph nodes, 

and gross lesions. Liver and kidneys-were weighed and relative organ weights calculated. The 

carcinogenic aspects of the study are considered negative at 5000 ppm (HDT), which is less than 

the MTD since no toxicity was observed. However, it should be considered that the HDT is 

about 25% of the LD50 dose for SDDBS.

According to the report, overall survival exceeded 56% with the highest rate (68%) occurring in 

animals on 0.5% test diet as compared with 53% in controls. There were no treatment related 

findings in hematology, histopathology or tumor results. Chronic interstitial nephritis and adrenal 

telangiectasis were the most commonly observed degenerative conditions. The majority of 

tumors were subcutaneous fibroadenomas. No data were presented to substantiate these 

statements.

Core Classification: ACCEPTABLE/guideline

Mutagenicity 

Adequacy of data base for Mutagenicity: The data base for Mutagenicity is considered adequate.

No additional studies are expected to be required at this time.

Gene Mutation

Guideline 870.5100, Study type: Gene Mutation - bacterial

MRID No. 43498429

Classification: Literature, acceptable

Negative at cytotoxic levels or limit concentrations (both with and without S-9 metabolic 

activation) when tested with Salmonella typhimurium - TA 98 and TA 100 strains.

Cytogenetics
Page 41 of 63

Guideline 870.5385, Study type: Structural Chromosomal Aberrations

MRID No. 43498428

Classification: Literature, acceptable

LAS were administered to rats in the diet for 90-days at doses of 0, 280, or 565 mg/kg/d. All test 

preparations were negative for increased chromosomal damage over controls.

Other Genotoxicity

Guideline 870.5300, Study type: In Vitro cell transformation

MRID No. 43498429

Classification,: Literature, acceptable

LAS tested negative in Syrian Hamster Ovary (SHE) cells at up to 50 micrograms/plate.

4.8 Neurotoxicity

In the available literature there was no toxicological information to indicate that this chemical 

had a neurotoxic effect.

4.9 Metabolism

Adequacy of data base for Metabolism: The database for metabolism is considered to be

complete. No additional studies are expected to be required at this time.

870.7485 Metabolism – Rat; MRID 43498431

In a rat metabolism study (MRID 43498431), groups of Charles- River CD male rats, 150-200 g

BW, were used in the study. LAS- 35S was given orally to fasted rats at doses of 0.6, 1.2, 8, and

40 mg. Urine and feces were collected and analyzed for radioactivity. Tissues were taken for

assay at the end of the study. For metabolism studies, urine, bile, or feces were pooled. The rate 

and distribution of the excreted dose was independent of concentration. Similar levels of

radioactivity were found in urine and feces and within 3 days, 85.2% - 96.6% of the label was

recovered in the high dose rats, no detectable radioactivity was found in the carcasses after 3

days. The limit of sensitivity was 0.1% of the dose. Urinary 35S was not in inorganic form and no

intact LAS- 35S was detected. Following methylation, one urinary metabolite was identified as 4-

(4’- methylsulfophenyl) pentanoate. LAS35S in the feces remained un-metabolized. The 

absorption in rats with a ligated bile duct by a single gavage dose of 1.2 mg LAS35S

demonstrated that gastrointestinal absorption did not require enterohepatic circulation, since

most of the oral dose was found in the urine (74%) and only 9% was found in feces. Recovery

was 83%.

Enterohepatic recirculation was found to be not an important factor in LAS - 35S excretion by

studies in rats with cannulated bile ducts given 1.2 mg/kg of LAS35S orally. The percent of

radioactivity in bile was similar to that in feces and most label was in the urine.

Core Classification: ACCEPTABLE
Page 42 of 63

Metabolism – Monkey; MRID No 43498410

In a monkey metabolism study (MRID No 43498410), two groups of 2 male and 2 female

Rhesus monkeys, 5 kg BW, were used for the oral and subcutaneous metabolism studies (one

group for each route of exposure). For the oral studies, each animal, following 2-3 weeks

between dose levels, received single oral doses of 14C (SDDBS; 25 microcuries) at levels of 30,

150, and 300 mg/kg. Blood, urine, faces and cage washing samples were taken for mass balance,

metabolite identification and plasma kinetics. Following 2-3 weeks after the last single oral dose,

each monkey received 7 consecutive daily oral doses of 30 mg/kg/day of 14C LAS. Animals were 

sacrificed after the last dose and tissue samples taken for direct combustion.

For the subcutaneous studies, each animal, following 2-3 weeks between dose levels, received

single subcutaneous doses of 14CLAS (SDDBS; 25 microcuries) at levels of 0.1, 0.5 and 1.0

mg/kg. Blood, urine, feces and cage washing samples were taken for mass balance, metabolite

identification and plasma kinetics. Following 2-3 weeks after the last, single subcutaneous dose,

each monkey received 7 consecutive daily subcutaneous doses of 1.0 mg/kg/day of 14 C LAS.

Animals were sacrificed after the last dose and tissue. samples taken for direct combustion. After 

single 30 mg/kg doses the radioactivity was rapidly excreted, mostly during the first 24 hours. 

Feces and urine contained 23.1% and 71.2%, respectively, in the first 5 days after oral dosing. 

After subcutaneous injection, 10.9% and 64.1% were found in the urine and feces, respectively, 

after the same period.

Plasma concentrations were comparable after single oral doses of 30, 150, and 300 mg/kg at 4

hours and averaged 34, 41, and 36 μ/ml, respectively. Peak plasma concentrations increased

proportional to dose after single subcutaneous injections of 0.1, 0.5, and 1 mg/kg and were 0.16,

0.72, and 1.13 μ/ml, respectively.

During the 7 day dosing period, either by oral or subcutaneous injection, there was no

accumulation of radioactivity in plasma, since peak concentrations and half-lives were similar

after the first and seventh dose. Animals sacrificed after the seventh dose showed no localization

in any of the examined tissues. In urine samples analyzed for metabolites, there was no

unchanged SDDBS and the 5 metabolites detected were polar, but were not sulphate or

glucuronide conjugates.

Core Classification: ACCEPTABLE

870.7600 Dermal Absorption – Rat

Studies (Howes, 1975) with isolated human skin preparations as well as in vivo investigations of 

percutaneous administration of LAS to rats have demonstrated that penetration through skin and 

subsequent systemic absorption of this surfactant does not occur to any significant extent at 24 to 

48 hours. 14 C-LAS was applied on the clipped dorsal skin of the rats, which was washed after 15 

min. No radioactivity was detected in urine or feces.

Table 15 – Subchronic/Chronic and Other Toxicity Studies

Guide 

No/Study Type 

MRID No./Referrence 

Information/study 

Classification

Dosing and Animal 

Information

Results
Page 43 of 63

Subchronic Toxicity

870.3100

Oral Subchronic

(rodent)

Ikawa et al., (1980)/

Ann. Rep. Tokyo Metrop. Res. 

Lab. Public Health. 29(2): 51-

54(Z). 1978 (in Japanese, see 

WHO, 1996 and HERA, 

2004).

Open Literature

LAS was administered for 

2, 4, or 12 weeks at a 

single dose of 1.5% in the 

diet (750 mg/kg/d).

Male rats (five/group)

Purity not reported.

LAS suppressed body weight 

gain and the relative liver weight 

was increased after two weeks.

Serum biochemical alterations 

included: significant increases in 

ALP, GTP (at 2, 4, 12 weeks); 

significant decreases in 

cholesterol and protein (4 

weeks); decreases in liver 

enzymes G6Pase and G6PDH 

and increases in isocitrate DH 

(all at 2, 4, 12 weeks). The 

following enzymes associated 

with kidney function were also 

altered: decreases in G6Pase, 

5’nucleotidase (at 2, 4, 12 

weeks) and Na,K-ATPase (12 

wks); increase in LDH (12 wks) 

and IDH (2,4 wks).

870.3100

Oral Subchronic 

(rodent)

MRID No. 43498412 Kay et 

al. (1965) Subacute Oral 

Toxicity of a Biodegradable, 

Linear Alkylbenzene 

Sulfonate. Toxicol Appl. 

Pharmacol. 7: 812-818 

(HERA)

Acceptable

Guideline

SDDBS administered in 

the diet at dietary levels of 

0, 200, 1000, and 5000 

ppm for 90 days

Weanling Sprague-Dawley 

Rat (10/sex/dose)

Purity: 87.9% a.i.

NOEL: 5000 ppm (HDT)

Two low dose males died early 

in the study from respiratory 

illness There was no compoundrelated effects in body weight, 

food consumption, hematology, 

urine analysis, organ weight, and 

histopathology.

870.3100

Oral Subchronic 

(monkeys)

MRID No. 43498413

Heywood et al. (1978) 

Toxicology Studies of Linear 

Alkyl Sulfonate (LAS) in 

Rhesus Monkeys I. 

Simultaneous Oral and 

Subcutaneous Administration 

for 28 Days. Toxicol. Appl. 

Pharmacol. 11: 245-250.

(HERA)

Acceptable

Guideline

LAS was given to four 

groups of three males and 

three females at doses of 

30, 150, 300 mg/kg 

bw/day per gavage (po) 

and simultaneously with 

0.1, 0.5, or 1.0 mg/kg 

bw/day

subcutaneously (sc). 

Control groups were used.

Rhesus Monkey 

(3/sex/dose), 18-36 months 

old

Purity: Not Reported

At 300 (po) and 1.0 (sc) mg/kg 

bw/day, the monkeys

vomited frequently and usually 

within 3 hours of administration. 

An increased frequency of loose 

or liquid faeces was recorded for 

animals receiving 150 (po) and 

0.5 (sc) mg/kg bw/day. These 

effects

are probably related to the 

inherent irritative effects of LAS 

rather than to its systemic 

toxicity.

Fibrosis of the injection sites was 

found among the entire test 

group, the incidence and severity 

being

dose related. Ophthalmoscopy, 

laboratory examination of blood 

and urine, organ weight analysis 

and

histopathological investigation 

did not detect any further 

treatment-related responses.

The LOAEL is 150 mg/kg 

bw/day (po) + 0.5 mg/kg bw/day 

(sc) based on an increase in 
Page 44 of 63

liquid feces and the NOAEL is 

30 mg/kg/d

Developmental Toxicity

870.3700a

Developmental 

Toxicity 

(rodent)

MRID 43498424 and 

43498425

Nomura, T et al. (1980) The 

Synthetic Surfactants AS and 

LAS Interrupt Pregnancy in 

Mice. Life Sciences, 26: 49-

54. (HERA)

Nomura, T. et al. (1987) 

Killing of Preimplantation 

Mouse Embryos by AS and 

LAS. Mutation Research 190: 

25-29. (HERA)

Acceptable

Guideline

LAS (0.1 ml ) was applied 

at a concentration of 20% 

to the dorsal skin of 

pregnant mice during the 

pre-implantation period

twice a day from day 0 to 

day 3 of pregnancy

Female ICR/Jcl Mouse, 

9-10 weeks old

Purity: 20%

Development was retarded and 

cleavage of eggs was interrupted.

Significantly higher numbers of 

embryos were found to be 

deformed in the LAS group in 

comparison to controls, and most 

of these embryos were in the 

morula stage, whereas they were 

mostly in the last blastocyst 

stage in controls.

Some dead, deformed, and 

growth-retarded embryos were 

observed in the treated group.

Although the authors stated that 

these effects were not due to 

maternal toxicity since no 

maternal organs were affected, 

this statement is probably not 

correct in view of the high 

concentration of LAS and its 

irritation effects. A secondary 

effect due to maternal toxicity 

appears much more likely.

870.3700a

Developmental 

Toxicity 

(rodent)

MRID 43498426

Palmer et al. (1975) 

Assessment of the Teratogenic 

Potential of Surfactants, (Part 

I), Toxicology 3: 91-106.

Acceptable

Guideline

LAS was administered by 

gavage on days 6-15 of 

pregnancy in rats and mice 

and days 6-18 of 

pregnancy in rabbits at 

doses of 0.2, 2, 300, and 

600 mg/kg bw/d 

20 CD Rats, 20 CD-1 

Mice, and 13 New Zealand 

White Rabbits

Purity: 17%

NOAEL (rat - maternal): 300 

mg/kg bw/d

NOAEL (mouse - maternal): 2.0 

mg/kg bw/d (However, there is a 

large difference between this 

dose and the next highest dose of 

300 mg/kg bw/d, this study does 

not allow determination of a 

reliable maternal NOAEL for 

mice) 

NOAEL (rabbit - maternal): 2.0 

mg/kg b/d (However, the study 

does not allow determination of 

reliable NOAELs, given the 

large difference between the 

maternal no-effects doses of 2 

mg/kg bw/d and the maternal 

LOAEL dose (300 mg/kg bw/d) 

that is also the dose for which 

effects on litters could not be 

determined due to the high 

mortality rate in parent animals) 

NOAEL (rat - developmental): 

300 mg/kg bw/d 

NOAEL (mouse -

developmental): 2.0 mg/kg bw/d

NOAEL (rabbit -
Page 45 of 63

developmental): 2.0 mg/kg bw/d

NOAEL (rat - fetal): 600 mg/kg 

bw/d

NOAEL (mouse - fetal): 300 

mg/kg bw/d (Due to a high 

mortality rate of parent animals, 

no assessment was possible at 

600 mg/kg bw/d)

NOAEL (rabbit - fetal): could 

not be determined

870.3700a

Developmental 

Toxicity 

(rodent)

MRID 43511403

Palmer, et al. (1975) 

Assessment of the Teratogenic 

Potential of Surfactants, (Part 

III) - Dermal Application of 

LAS and Soap. Huntingdon 

Research Centre, Huntingdon, 

Great Britain. Study No. 

DDBSA JV-RP4-029.

Toxicology 4: 171-181.

Acceptable

Guideline

LAS was administered 

percutaneously to shaved 

skin at solutions of 0.03%, 

0.3%, and 3% during 

pregnancy on days 2-13 in 

mice, 2-15 in rats, and 1-

16 in rabbits. Dosages 

employed were 0.5 ml/rat 

or mouse/day and 10 

ml/rabbit/day 

CD-1 Mice (20/group), CD 

Rats (20/group), N2W 

Rabbits (13/group)

Purity: 0.03%, 0.3%, and 

3%

LOEL (maternal toxicity, mice): 

0.3% (50 mg/kg/d) 

LOEL (maternal toxicity, rats): 

3.0% (60 mg/kg/d)

LOEL (maternal toxicity, 

rabbits): 0.3% (9.0 mg/kg/d)

NOEL (maternal toxicity, mice): 

0.03% (5.0 mg/kg/d)

NOEL (maternal toxicity, rats):

0.3% (6.0 mg/kg/d)

NOEL (maternal toxicity, 

rabbits): 0.03% ((0.9 mg/kg/d)

LOEL (developmental toxicity): 

0.3% (50 mg/kg/d)

LOEL (developmental toxicity): 

3.0% (60 mg/kg/d)

LOEL (developmental toxicity): 

3.0% (90 mg/kg/d)

NOEL (developmental toxicity): 

0.03% (5.0 mg/kg/d)

NOEL (developmental toxicity): 

0.3% (6.0 mg/kg/d)

NOEL (developmental toxicity): 

0.3% (9.0 mg/kg/d)

Marked local skin reaction, 

irritability, weight loss and 

failure to maintain or establish 

pregnancy was evident in mice 

treated with LAS 3% soap, 3 or 

30%: marked local reaction and 

weight loss also occurred in 

rabbits receiving LAS 3%.

Moderate maternal toxicity was 

observed among mice treated 

with LAS, 0.3% and mild 

maternal toxicity in rats 

receiving LAS 3% or soap 30% 

and rabbits receiving LAS 0.3%.

Effects on litter parameters were 

dose-dependent, causing marked 

maternal toxicity in mice, the 
Page 46 of 63

principal higher fetal loss,

reduction in viable litter size. 

LAS at 3% showed marked 

maternal toxicity in the rabbit

The moderate maternal toxicity 

of LAS, 0.3% in the mouse 

correlated with a higher 

incidence of embryonic deaths 

and lower litter size but only the 

former differed significantly 

from the corresponding control 

value.

Reproduction Toxicity

870.3800

Reproduction

MRID 43498416

Buehler, E., Newmann, E., and 

King, W. (1971) Two Year 

Feeding and Reproduction 

Study in Rats with Linear 

Alkylbenzene Sulfonate 

(LAS). Tox. Appl. Pharm. 18: 

83-91. (HERA)

Acceptable

Guideline

LAS was administered in 

the diet at doses of 0, 0.02, 

0.1, and 0.5% , equivalent 

to (0, 10, 50, 250 mg/kg 

bw/day) for 84 days.

Weanling Charles River 

CD Rat (20/sex/dose)

Purity: 98.1%

NOAEL Parental: 250 mg/kg 

bw/day

NOAEL Offspring: 50 mg/kg/d.

The LOAEL of 250 mg/kg/day 

in the offspring is due to slight 

(non-significant) changes in 

hematology and histopathology 

and slight decrease in day 21 

body weights.

Chronic Toxicity

870.3100

Chronic 

Toxicity

(rodent)

Yoneyama et al. (1976) 

Subacute Toxicity of LAS, 

Ann. Rep. Tokyo Metrop. Res. 

Lab. Public Health27(2): 105-

112, See: IPCS, 1996. (HERA)

Open Literature

LAS was administered for 

9 months in the drinking 

water at doses of 85, 145, 

430 mg/kg bw/day 

M/F Wistar Rat

Purity: Not Reported

NOAEL: 85 mg/kg bw/d

LOAEL: 145 mg/kg bw/d

Haematological examination 

revealed no significant changes 

in any experimental group and 

no organ

weight changes were observed. 

Body weight gain was 

suppressed in the males of the 

highest dose

group and also serumbiochemical and enzymatic 

parameters of the liver and 

kidney were affected. A

significant decrease in renal 

Na,K-ATPase was seen in the 

group given 145 mg/kg bw/day 

of LAS.

Carcinogenicity

870.4200a

Oncogenicity 

(Rat)

MRID 43498416

Buehler, E., Newmann, E., and 

King, W. (1971) Two Year 

Feeding and Reproduction 

Study in Rats with Linear 

Alkylbenzene Sulfonate 

(LAS). Tox. Appl. Pharm. 18: 

83-91. (HERA)

Acceptable

Guideline

LAS was administered in 

the diet at doses of 10, 50, 

and 250 mg/kg/day for 2 

years

Weanling Charles River 

CD Rats (50/sex/group)

Purity: Not Reported

Negative at 250 mg/kg/day 

(HDT)
Page 47 of 63

870.4200a

Oncogenicity 

(Rat)

MRID 43498420

Takahasi et al. (1969) Effect 

of Alkylbenzenesulfonate as a 

Vehicle for 4-Nitroquinoline1-Oxide on Gastric 

Carcinogenesis in Rats.

GANN: 8, 241-261.

Acceptable

Guideline

For 560 days; Group I (79 

rats): 1 mg 4-NQO and 80 

mg SDDBS 2-3x per week 

for 18 weeks; Group I' (17 

rats): same as Group 1, but 

fasted for 12 hours prior to 

dosing,; Group II (37 rats):

1 mg 4-NQO only; Group 

III (28 rats): 80 mg 

SDDBS only

97 M Wistar Rats

Purity: Not Reported

In Groups I and I', the presence 

of SDDBS shifts the incidence of 

benign papillomas to malignant 

papillomas of the forestomach

and the incidence of 

adenocarcinoma and sarcoma of 

the stomach were increased in 

comparison to Group II with 

only 4-NQO. The administration 

of SDDBS by itself has no effect 

on gastric tumors (Group III).

The study authors concluded that 

the increased carcinogenicity 

produced by SDDBS was due to 

the better uptake of 4-NQO via 

LAS's surfactive/detersive 

effects on the protective mucous 

barrier which is normally found 

in the glandular stomach and 

other gastric compartments of 

the rat. The effect of SDDBS 

was physical rather than 

chemical in promoting the 

increased tumorigenicity.

Mutagenicity

870.5385

Mammalian 

bone marrow 

chomosomal 

aberration test

MRID 43498428

J. Hope (1977) Absence of 

Chromosome Damage in the 

Bone Marrow of Rats Fed 

Detergent Actives for 90 Days.

Mutation Research, 56: 47-50.

Acceptable

Guideline

SDDBS was administered 

in the diet for 90 days at 0, 

280, and 565 mg/kg bw/d 

Colworth/Wistar Weanling 

Rat (6/sex/dose)

Purity: Not Reported

All test preparations were 

negative for increased 

chromosomal damage over 

controls.

870.5100

Bacterial 

reverse 

mutation test

MRID 43498429

Inoue et al. (1980) Studies of 

In Vitro Cell Transformation 

and Mutagenicity by 

Surfactants and other 

Compounds, Food. Cosmet. 

Toxicol 18: 289-296. (HERA)

Acceptable

Guideline

SDDBS was tested at 

cytotoxic levels or limit 

concentrations of 2,000-

30,000 ug/plate for 2 days 

(Salmonella) or 8 days 

Strain: Salmonella 

typhimurium - TA 98 and 

TA 100 cells and 

Embryonic Syrian Golden 

Hamster cells (SHE) 

Purity: Not Reported

Negative (both with and without 

S-9 metabolic activation)

870.5385

Mammalian 

bone marrow 

chomosomal 

aberration test

Inoue K, et al. (1979) In vivo 

Cytogenetic Tests of Some 

Synthetic Detergents in Mice, 

Ann. Rep. Osaka Perfect. Inst. 

Public Health 8: 17-24 (in 

Japanese), See: IPCS, 1996.

(HERA)

Open Literature

LAS was administered at 

doses of 200, 400, and 800 

mg/kg bw/d by gavage for 

1 and 5 days

M Mouse

Purity: Not Reported

There was no significant 

difference in the incidence of 

chromosomal aberrations 

between any of the groups
Page 48 of 63

Metabolism

870.7485 

General 

Metabolism

MRID 43498410

Creswell et al. (1978) 

Toxicology Studies of Linear 

Alkylbenzene Sulfonate (LAS) 

in Rhesus Monkeys II. The 

Disposition of 14C-LAS After 

Oral or Subcutaneous 

Administration. Toxicology, 

11: 5-17.

Unacceptable

Not Guideline

Single oral doses of 14CLAS (SDDBS; 25 μcuries) 

were administered to each 

animal, following 2-3 

weeks between dose 

levels, at levels of 30, 150, 

and 300 mg/kg. Following 

2-3 weeks after the last 

single oral dose, each 

monkey received 7 

consecutive daily oral 

doses of 30 mg/kg/d of 

14C-LAS.

2 M/2 F Rhesus Monkeys

Purity: Not Reported

After single 30 mg/kg doses the 

radioactivity was rapidly 

excreted, mostly during the first 

24 hours. Feces and urine 

contained 23.1% and 71.2%, 

respectively, in the first 5 days 

after oral dosing. Plasma 

concentrations were comparable 

after the oral doses and averaged 

34, 41, and 36 u/ml, respectively.

Peak plasma concentrations 

increased proportional to the 

dose and were 0.16, 0.72, 1.13 

u/ml, respectively. In urine 

samples analyzed for 

metabolites, there was no 

unchanged SDDBS and the 5 

metabolites detected were polar, 

but were not sulphate or 

glucuronide conjugates.

870.7485 

General 

Metabolism

MRID 43498431

W. Michael (1968) 

Metabolism of Linear Alkylate 

Sulfonate and Alkyl Benzene 

Sulfonate. Toxicol. Appl. 

Pharmacol. 12: 473-485.

Acceptable

Not Guideline

LAS35S was administered 

orally to fasted rats at 

doses of 0.6, 1.2, 8, and 40 

mg

Charles River CD M Rat

Purity: Not Reported

The rate and distribution of the 

excreted dose was independent 

of concentration. 

Similar levels of radioactivity 

were found in urine and feces 

and within 3 days, 85.2% -

96.6% of the label was 

recovered. 

In the high dose rats, no 

detectable radioactivity was 

found in the carcasses after 3 

days.

Following methylation, one 

urinary metabolite was identified 

as 4-(4'-methylsulfophenyl) 

pentanoate. 35LAS-S in the feces 

remained unmetabolized.

Summary of Previously Selected Toxcological Dose and Endpoints for Linear 

Alkytlbenzene Sulfonates

Table 16 – Endpoints to be Reevaluated Using the Most Current Acceptable Data

Summary of Toxicological Dose and Endpoints for ABS

Exposure 

Scenario

Dose used in Risk 

Assessment, UF

Special FQPA 

SF* endpoint 

and Level of 

Concern for 

Risk Assessment

Study and Toxicological 

Effects

Acute Dietary No endpoint was selected. No effects are attributable to a single dose
Page 49 of 63

(all populations) 

Chronic Dietary

(All populations)

Systemic/Reproductive

NOAEL = 50

mg/kg/day

UF = 100

Chronic RfD = 0.5 

mg/kg/day 

FQPA SF = 1X

cPAD =

chronic 

RfD/FQPA SF

= 0.5 mg/kg/day

Systemic/Reproductive 

LOAEL = 250 mg/kg/day 

based on Decreased Day 21 

female pup body weight 

(Buehler, E. et. al 1971. 

Tox, Appl. Pharmacol. 

18:83-91)

plus

LOAEL = 145 mg/kg/day 

from 9 month drinking 

water rat study based on 

decreased body weight 

gains, and serum/ 

biochemical and enzymatic 

changes in the liver and 

kidney (Yoneyama et al. 

1976 Ann. Rep. Tokyo 

Metrop. Res. Lab. Public 

Health 27(2):105-112)

plus

LOAEL = 114 mg/kg/day 

(0.2%) based on increased 

cacum weight and slight 

kidney damage in a 6 

month rat dietary study 

(Yoneyama et al 1972 Ann. 

Rep. Tokyo Metrop. Res. 

Lab Public Health 24:409-

440) 

Short-Term

Incidental Oral (1-

30 days)

Oral NOAEL = 50 

mg/kg/day

Residential 

LOC for 

MOC = 100

Systemic/Reproductive LOAEL = 250 mg/kg/day 

based on decreased Day 21 female pup body 

weight (Buehler, E. et. al 1971. Tox, Appl. 

Pharmacol. 18:83-91)

plus

LOAEL = 145 mg/kg/day from 9 month drinking 

water rat study based on decreased body weight 

gains, and serum/biochemical and enzymatic 

changes in the liver and kidney (Yoneyama et al. 

1976 Ann. Rep. Tokyo Metrop. Res. Lab. Public 

Health 27(2):105-112)
Page 50 of 63

plus

LOAEL = 114 mg/kg/day (0.2%) based on 

increased cacum weight and slight kidney damage 

in a 6 month rat dietary study (Yoneyama et al

1972 Ann. Rep. Toko Metrop. Res. Lab Public 

Health 24:409-440)

Short, intermediate 

and Long-Term 

Inhalation (1-30 

days, 1-6 months, 

>6 months)

Inhalation study 

NOAEL = 1 mg/m3

detergent dust 

combined with up to 

0.1 mg/m3 enzyme 

dust equivalent to app. 

0.14 mg/kg/day (a) 

(inhalation absorption 

rate = 100%)

Purity = 13% active 

ingredient

Residential 

LOC for 

MOE =100

Occupational 

LOC for 

MOE = 100

Subchronic Inhalation Monkey Study LOAEL = 

10 mg/m3 detergent combined with 0.1 mg/m3 

enzyme dust based on weight loss and decreased 

weight gain (W. Coates, et. al 1978. Tox Appl. 

Pharmacol. 45:477-496). This air concentration is 

equivalent to approximately 1.4 mg/kg/day (a)

Cancer (oral, 

dermal, inhalation) No evidence of carcinogenicity in reported studies in rats done before 1980 GLPs

Dermal Endpoint

Qualification of dermal risk is not required since: 

1) the alkylbenzene sulfonates are surfactants that 

are dermal irritants at concentrations generally 

greater than 20% solution. (WHO 1996). Thus, 

dermal exposure would be self –limiting to 

preclude dermal irritation. Most pesticide 

formulations have less 5% alkylbenzene 

sulfonates as an inert ingredient, with the vast 

majority containing app 2%.

(2) no systemic toxicity was seen following 

repeated dermal application of 200 mg/kg/day 

(with an end use product)

3) no developmental toxicity concerns were seen 

following repeated dermal application to pregnant 

mice, rats or rabbits (development effects were 

seen either in the presence of maternal toxicity or 

at doses higher than those that caused maternal 

toxicity);

4. There is no residential exposure to 
Page 51 of 63

alkylbenzene sulfonates as an active ingredient, 

however, residential exposure from its use as an 

inert ingredient in pesticide formulation is 

expected to be an intermediate nature (i.e. no 

continuous, constant contact, multi-day exposure) 

from household products.

Additional References

Assaad, A. Dykstra, Alkylbenzene Sulfonates (ABS) Toxicology Chapter for the 

Reregistration Eligibility Decision (RED) Document. PC Code: 079010, 190116 and 098002.

Case No. 4006. DP Barcode: D327886., Doc. # EPA-HQ-OPP-2006-0156-0003.

Registration Eligibility Decision for Alkylbenzene Sulfonates, United states Environmental 

Protection agency, Prevention, pesticides and Toxic Substances, EPA 739-R-06-006, July 2006. 

Tao, J. Response to Waiver Request Submitted for the Alkylbenzene Sulfonates RED DCI, Feb. 
Page 52 of 63

Appendix B Dietary Profile

Indoor Food Use Patterns

Dodecylbenzenesulfonic acid (098002):

• Beverage Processing Plant Premises

• Commercial Transportation Facilities-Feed/Food-Empty

• Dairies/cheese processing plant equipment

• Dairy farm milk handling facilities/equipment

• Dairy farm milking equipment

• Eating establishment

• Eating establishment equipment/utensils

• Egg handling rooms 

• Egg packing plants

• Food dispensing equipment/vending machines

• Food processing plant equipment

• Meat processing plant equipment

• Poultry processing plant equipment

• Beverage Processing Plant Premises

Dodecylbenzenesulfonic acid, Sodium Salt (079010):

• Commercial/institutional/industrial premises/equipment

• Food processing water systems

• Fruit and vegetable wash used in or on:

o Artichoke

o Beets

o Brassica (head and stem)

o Bulb vegetables

o Citrus

o Watercress

o Cucurbit vegetables

o Flavoring/spice crops

o Fruiting vegetables

o Grapes

o Leafy vegetables

o Legume vegetables

o Mushrooms

o Pome Fruits

o Root and tuber vegetables

o Small fruits

o Stone fruits

o Subtropical/tropical fruit

o Turnips (greens)

o Other miscellaneous vegetables
Page 53 of 63

Appendix C Environmental Fate

Environmental Fate Properties

Except for a couple of studies, registrants have submitted studies primarily from the open 

literature to support uses of ABS rather than conducting their own studies. Not all open literature 

studies submitted have been reviewed because at the time of registration a limited data set was 

required. Studies that were conducted and submitted by registrants include a hydrolysis study 

(MRID 40548801 and 40970701) and a soil leaching/adsorption/desorption study (MRID 

40655201 and 94032011), which have been reviewed and were found acceptable for conducting 

a risk assessment. Additional open literature studies have been obtained by the agency. Where 

literature studies have not been reviewed, interim modeled values using EPI Suite version 4.1 

were used. The major difference between the two actives considered in this case are the ions on 

the sulfonate groups which are sodium versus hydrogen respectively, both ionize. A summary of 

the abiotic and biotic fate studies which have been submitted are summarized in Table 17 and 

Table 18, respectively. Estimated parameters using EPISuite v4.1 are provided in Table 19.

Abiotic Parameters

Hydrolysis

A hydrolysis study (40548801, 40970701 and 40970701) was conducted with sodium 

dodecylbenzene sulfonate at pH 5, 7, and 9 demonstrating that it is stable. 

Photodegradation in Air

The predicted extremely low vapor pressure for these actives (Table 19) indicates that it is 

unlikely that any significant amounts of ABS will be in the atmosphere for photodegradation to 

be of concern. Additionally, the short atmospheric half life of approximately 8 hours indicates 

that any atmospheric ABS would degrade rapidly by reaction with photochemically produced 

hydroxyl radicals in air.

Photodegradation in Water

One open literature study was submitted for photodegradation in water (MRID 163341, Hidaka 

et al. 1985). A half-life of <1-2 days for the benzene ring and a slower rate for the alkyl chain 

was reported. The study has not been reviewed, and given that biodegradation is the major 

dissipation pathway this was not considered a critical data requirement.

Soil Leaching/Adsorption/Desorption

One study was submitted (MRID 40655201 and 94032011) and found to be acceptable (Table 

17). The results of the adsorption/desorption study indicate medium mobility of sodium 

dodecylbenzene sulfonate on sandy loam soil, low mobility on silty loam soil, and slight mobility 

on the other soils. Jacobsen (2004) identified that the sorption of LAS to soil is a combination of 

several mechanisms and sorption to both the organic and inorganic fraction of the soil has been 

demonstrated. The linear alkyl group of LAS is hydrophobic and sorbs to the non-polar fractions 
Page 54 of 63

of the soil, such as the organic matter. However, the sulfonate group of LAS is negatively 

charged and hydrophilic and therefore interacts with positively charged soil components or polar 

groups, such as hydroxyl-groups, minerals, or oxides.

Table 17 - Abiotic Degradation of ABS

Parameter Test Substance Half-lives 

Source/

Study Classification/

Comments

Hydrolysis Sodium 

dodecylbenzene 

(LAS)

[Ring-U- 14C]benzene 

sulfonate

Stable at pH 5, 7, 9 buffers 

(monobasic/dibasic potassium 

phosphate buffers) at 25o

C

MRID 40548801, 40970701 

and 40970701

Korsch 1988a; Korsch 

1988b, Keene, 1990, 

respectively

Acceptable

Photodegradation in 

water

Sodium 

dodecylbenzene 

sulfonate

Half life <1-2 hours for 

aromatic ring

Half life for the akyl group

MRID 163341, Hidaka et al. 

1985/

Not reviewed

Soil Leaching/ 

Adsorption/Desorption

Sodium 

dodecylbenzene 

sulfonate

Silt Clay Loam Soil

KF 20.3

1/N (slope) 0.8560

Koc 1400

MRID 40655201 and 

94032011; Korsch and 

Kapostasy, 1988 and Keene, 

1990/

Silty Loam Soil Acceptable

KF 13.3

1/N (slope): 0.8893

Koc 2280

Sandy Loam Soil

KF 6.9

1/N (slope): 1.002

Koc 390

Sandy Soil

KF 3.6

1/N (slope): 1.095

Koc 2680

Activated sludge 

sorption isotherm

LAS (C12-

homologue)

Batch experiments

Kp = 3.21 g-1 VSS

Equilibrium achieved within 5-

10 minutes

Pilot-plant monitoring data

Kp = 3.71 g-1 VSS

Temmink and Klapwijk, 

2004’

Not reviewed
Page 55 of 63

Table 18 - Biotic Degradation of ABS

Parameter Test Substance Half-lives 

Source/

Study Classification/

Comments

Aerobic aquatic 

metabolism

162-4

Commercial LAS 

mixture with a C12

LAS homologue 

labeled with 14C in 

the benzene ring 

added

Half life alkyl group 0.23 

days (5.52 hours)

Half life benzene ring 0.73 

days (17.5 hours)

Larson and Payne, 1981/

Supplemental/

Tested at 0.05 and 0.5 

mg/L LAS

Biodegradation in 

Activated Sludge

LAS (C12-

homologue)

Pilot-scale municipal waste 

plant study: >99% LAS load 

removed by biodegradation

92-98% of remaining LAS 

load adsorbed to sludge

Ready Biodegradation Study 

(OECD 301F) >60% 

mineralization was achieved 

within 28 days and this level 

was reached within a time 

window of 10 days

Temmink and Klapwijk, 

2004/

Not reviewed

t0.5 = 0.6-0.7 hours (primary)

t0.5 = 1.3 – 1.4 hours 

(ultimate)

Federle et al., 1997

Table 19—Estimated Physical Properties

Property Structure Estimation 

Program LAS (CAS #25155-30-0) LAS acid (CAS #27176-87-0)

Koc (L/kg) KOCWIN v2.00 MCI method 1.238E+004 (log Koc = 4.093) 1.238E+004 (log Koc = 4.093)

Melting Point MPBPVP v1.63 144.5 oC 1 177.76 oC

Boiling Point MPBPVP v1.63 Note decomposition onset at 

444 oC experimental data

459.93 oC

Vapor Pressure MPBPVP v1.63 2.29E-015 mm Hg 7.93E-011 mm Hg

Henry’s Law 

Constant

HENRYWIN v3.20 6.29E-008 atm-m3/mole 6.27E-008 atm-m3/mole

Atmospheric 

Oxidation

AopWin v1.92 Hydroxyl 

Radicals Reaction

Half life 7.9 hrs Half life 7.846 hrs

1 http://www.sciencelab.com/msds.php?msdsId=9923880

2 http://www.sciencelab.com/msds.php?msdsId=9923881
Page 56 of 63

Activated Sewage Sludge Sorption

An open literature study is available on sorption of LAS with activated sludge (Temmink and 

Klapwick, 2004). The Kd values for C12 LAS was 3210 L/kg with sorption and desorption 

equilibria being achieved within 5-10 minutes. This study will be reviewed prior to the Final 

Work Plan to determine if this open literature study can be used to fulfill this data requirement.

There is information that supports that sorption affinity decreases with increasing LAS 

concentration (Tolls and Sijm, 2000).

Bioconcentration

As a surface-active substance typical models for estimating bioconcentration factors (BCFs) are 

not applicable. There are techniques which can be used for such chemicals but such studies are 

not being required at this time because of the availability of actual bioconcentration studies in the 

open literature. Two studies from the open literature on the bioconcentration of LAS were 

submitted to support registration of LAS (MRID 44260006 and 44260013; Kimerle at al. 1981 

and Kikuchi et al. 1978, respectively). Additional studies are available in the open literature on 

linear ABS. BCFs using individual linear alkyl chains from C10 – C13 range from 1.7 to 1325 for 

fish, 99.1 to 4,100 for daphnia (Bishop and Maki, 1980; Tolls et al. 1994; Comotto et al., 1979; 

Kimerle et al., 1981; Gledhill et al., 1981) where BCF increases with increasing alkyl chain 

length. A BCF of 211.5 was reported for the estuarine/marine mussel, Mytilus edulis (Ekelund et 

al., 1990). These studies will be reviewed for the Final Work Plan.

Biotic Parameters

Activated Sludge Respiration Inhibition

Kwok (2011) conducted a respiration inhibition test using sodium dodecylbenzene sulfonate 

following ISO 8192 (1986) procedure. The IC50 was reported to be greater than 20 mg/L. An 

earlier work by Painter (1986) with sodium dodecylbenzene sulfonate using an OECD method 

reported an activated sludge inhibition of 100 mg/L.

Aerobic Aquatic Biodegradation

Several open literature studies have been submitted by registrants to address aerobic aquatic 

biodegradation; in addition the Agency is aware of additional studies from the open literature.

While not all the data has been reviewed by the Agency at this time to derive a final 

biodegradation rate for use in a risk assessment, these studies provide weight of evidence as to 

the fate of C12-ABS. The biodegradation reaction for LAS starts at the terminal carbon farthest 

from the position of attachment of the aromatic ring to the carbon chain and proceeds to the 

aromatic ring, cleaving two carbons at a time. The benzene ring is not degraded until degradation 

of the linear alkyl segment is completed. After the linear alkyl group is degraded the major 

biodegradation intermediates are sulfophenyl carboxylates (Swisher, 1987; Schoerl, 1989; 

Huddleston and Allred, 1963). These intermediates also degrade and mineralize into carbon 

dioxide, water and sulfate ions.
Page 57 of 63

Based on the available open literature the linear C12-ABS are expected to readily biodegrade as 

summarized in the following discussion. An early work by Larson and Payne (1981), on linear 

ABS using water samples collected from above and below a municipal WWTP discharge 

showed rapid degradation by the alkyl groups with a half life of 0.23 days (5.52 hours), while the 

same study showed that the benzene ring mineralized with a half life of 0.73 days (17.52 hours) 

as indicated by the amount of radiolabeled carbon dioxide collected.

Activated Sludge Biodegradation

In an activated sludge pilot-scale municipal waste plant monitoring study >99% of the LAS (C12-

homologue) load was removed by aerobic biodegradation (Temmink and Klapwijk, 2004).

Ready Biodegradation Studies (OECD 301F) were also conducted and found >60% 

mineralization was achieved within 28 days and that this level was reached within a time 

window of 10 days from initiation of mineralization (Temmink and Klapwijk, 2004). This study 

is under review for fulfilling this data requirement, and should be complete by the Final Work 

Plan.

Fate 

References in 

this 

Section163341

Hidaka, H.; Kubota, H.; Graetzel, M.; et al. (1985) Photodegradation of surfactants I; 

Degradation of sodium dodecylbenzene sul- fonate in aqueous semiconductor 

dispersions. Nouveau Journal de Chimie 9(2):67-69.

40548801 Korsch, B. (1988) A Hydrolysis Study with Sodium Dodecylbenzene Sulfonate: Project 

ID: 87-0098. Unpublished study prepared by Ricerca, Inc. 84 p.

40655201 Korsch, B.; Kapostasy, W. (1988) Asorption and Desorption of Sodium Dodecylbenzene 

Sulfonate to Soils: Project ID: 87-0115: Document No. 1710-87-0115-EF-001. 

Unpublished study prepared by Ricerca, Inc. 76 p.

40970701 Korsch, B. (1988) Supplement To: A Hydrolysis Study with Sodium Dodecylbenzene 

Sulfonate ...: Document No. 1675-87-0098-EF-001- 002: Project ID: 87-0098. 

Unpublished study prepared by Ricerca, Inc. 31 p.

41069601 Sobek, A. (1989) Supplement to: A Hydrolysis Study with Sodium Dodecylbenzene 

Sulfonate: Literature Review of Reactivity of Sodium Dodecylbenzene Sulfonate in 

Non-Sterile Media: Report Supplement Number Three: Document No. 89003-PS. 

Unpublished study prepared by BFGoodrich Co. 202 p.

94032010 Keene, E. (1990) The BF Goodrich Company/Promac Systems Phase 3 Summary of 

MRID 40548801. A Hydrolysis Study with Sodium Dodecylbenzene Sulfonate. Prepared 

by Ricerca, Inc. 37 p.

94032011 Keene, E. (1990) The BF Goodrich Company/Promac Systems Phase 3 Summary of 

MRID 40655201. Adsorption and Desorption of Sodium Dodecylbenzene Sulfonate to 

Soils. Prepared by Ricerca, Inc. 25 p.
Page 58 of 63

European Oilfield Speciality Chemicals Association. 2000. Summary Report Surfactant 

Bioaccumulation Review Project. 106 pp. http://www.eosca.eu/wpcontent/uploads/Surfactants-Report.pdf

Fairchild, James F, et. al. (1993). “Evaluation of a Laboratory-Generated OEC For Linear 

Alkylbenzene Sulfonate in Outdoor Experimental Streams.” Environmental Toxicology 

and Chemistry. Vol. 12. pp 1763-1776.

Federle TW and NR Itrich (1997), Comprehensive approach for assessing the kinetics of primary 

and ultimate biodegradation of chemicals in activated sludge: application to LAS, 

Environ. Sci. Technol. 31: 1178-1184.

Huddleston,RL, and Allred, RC. 1963. Microbial oxidation of sulfonated alkylbenzenes. 

Dev.Ind. Microbiol., vol.4, pp24-38

Jacobsen, Anne Marie, Gerda Krog Mortensen, and Hans Christian Bruun Hansen. (2004). 

Degradation and Mobility of Linear Alkylbenzene Sulfonate and Nonylphenol in SludgeAmended Soil. Journal of Environmental Quality. Vol 33. pp. 232-240.

Kwok, T.K. 2011. Assessing the effect of surfactants on activated sludge processes using 

sequencing batch reactors. Master’s Thesis Environmental Engineering, School of Civil, 

Environmental and Chemical Engineering, RMIT University. 111 pp. 

http://researchbank.rmit.edu.au/eserv/rmit:11997/Kwok.pdf

Larson, RJ, and Payne, AG. 1981. Fate of the Benzene Ring of Linear Alkylbenzene Sulfonate in 

Natural Waters. Applied Environ. Microbiol., vol. 41(3), pp 621-627

Painter, H. A. (1986) Testing the toxicity of chemicals by the inhibition of respiration of 

activated sludge. Toxicity Assessment 1:515-524.

Swisher, RD, 1987. Surfactant Biodegradation, second edition, Surfactant Science Series Vol.18, 

Marcel Dekker, Inc. New York, NY

Schoerl, P, 1989. Basic Principles of LAS Biodegradation, Tenside Surfactant Detergents, 26, pp 

86-94.

Temmink, H.and B. Klapwijk. 2004. Fate of linear alkylbenzene sulfonate (LAS) in activated 

sludge plants. Water Research 38:903-912.

Tolls and Sijm. 2000.
Page 59 of 63

Appendix D Ecotoxicology Profile

Terrestrial Organisms

Birds

An acute oral toxicity study using the technical grade of the active ingredient (parent 

compounds, i.e. TGAI) is expected to be required to establish the toxicity of ABS to birds. One 

avian acute test species is expected to be required for indoor uses for label hazard purposes. The 

preferred test species is either a waterfowl, the mallard duck (Anas platyrhynchos), or an upland 

game bird, the Northern bobwhite quail (Colinus virginianus). Data for the Northern bobwhite 

have been submitted for LAS (Table 20). This study indicates that LAS is slightly toxic to the 

Northern bobwhite quail on an acute-oral basis (LD50 > 500 ppm). The sodium dodecylbenzene 

sulfonate study (MRID 4113901) fulfills the guideline requirement (850.2100).

A sub-acute dietary study (850.2200) using TGAI may be required on a case-by-case basis 

depending on the results of lower-tier ecological studies and pertinent environmental fate 

characteristics, however, this testing is not expected to be required unless outdoor uses are added 

to alkylbenzene sulfonate labels.

Chronic data (850.2300) are not required.

Table 20 – Available Endpoints from Avian Ecotoxicity Studies for Sodium 

Dodecylbenzene Sulfonate

Study Type Species

Test 

material

(% ai)

Toxicity1 Toxicity 

Classification

MRID & 

Status

Acute – Avian 

Oral (850.2100)

Northern 

Bobwhite 87.6 LD50: > 1382 ppm Slightly toxic 41143901Acceptable

Mammals

In most cases, rat toxicity studies for human health risk assessments are used as surrogates for 

wild mammal testing. Wild mammal tests are not expected to be required for ABS at this time 

because the currently registered uses are indoor spray applications. Refer to the toxicology 

section for mammalian toxicity data.

Nontarget Insects

It was determined in the 2006 RED that minimal or no environmental exposure to terrestrial or 

aquatic organisms is expected to occur due to the fact that the use patterns were considered 

indoors. It has since been recognized that such use patterns may have an additional down-thedrain component resulting in potential releases to wastewater treatment plants (WWTPs) and 

subsequently the environment. Such releases for the linear 12 carbon chain ABS (C12-ABS) 

actives in this case are considered highly unlikely to be discharged from WWTPs due to sorption 
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and rapid biodegradation as discussed in Section 4.1. Therefore, no data are required because 

nontarget insects are highly unlikely to be exposed.

Aquatic Organisms

Freshwater Fish

In order to establish the acute toxicity of pesticides to freshwater fish for environmental hazard 

labeling, the agency expects to require a TGAI study for indoor uses having no environmental 

exposure of concern. The preferred test species is either a cold-water fish, Rainbow Trout 

(Oncorhynchus mykiss), or a warm-water fish, Bluegill Sunfish (Lepomis macrochirus). Two 

supplemental studies are listed in 

which indicate that LAS is moderately toxic to freshwater fish. The guideline requirement for a 

freshwater fish acute study has not been fulfilled and this data gap (850.1075) was identified in 

the 2006 RED. As a result of the 2006 RED one acute freshwater fish toxicity test using 

technical grade dodecylbenzene sulfonic acid (098002) should have been called in to the agency 

in order to support existing indoor uses, but was not. Because the only studies measuring the 

toxicity of LAS to freshwater fish were determined to be supplemental, HPV Challenge Program 

data were used in order to create a more comprehensive toxicity profile. The agency expects to 

obtain and review the specific data from the HPV Challenge Program in order to satisfy this data 

requirement (Table 13).

Table 21 – Available Endpoints from Freshwater Fish Ecotoxicity Studies for LAS

Study Type Species

Test 

material

(% ai)

Toxicity1 Toxicity 

Classification

MRID & 

Status

Acute – Freshwater Fish 

Toxicity (840.1075)

Fathead 

Minnow 14.0* LC50: 3.4 mg/L Moderately toxic 44260002Supplemental

Acute – Freshwater Fish 

Toxicity (840.1075)

Rainbow 

Trout 65.0% LC50: 1.68 mg/L Moderately toxic 44260009Supplemental

1 Toxicity values based on parent compound (TGAI)

* Carbon chain not identified

Freshwater Invertebrates

In order to establish the acute toxicity of pesticides to freshwater aquatic invertebrates for 

environmental hazard labeling, the agency expects to require a TGAI study for indoor uses 

having no environmental exposure of concern. The preferred test species is Daphnia magna or 

Daphnia pulex. One supplemental study is listed in Table 22. The results of this study indicate 

that the toxicity of LAS to freshwater invertebrates is variable, depending on the length of the 

carbon chain. The guideline requirement for a freshwater invertebrate acute study has not been 

fulfilled and this data gap (850.1010) was identified in the 2006 RED. As a result of the 2006 

RED one acute freshwater invertebrate toxicity test using technical grade dodecylbenzene 

sulfonic acid (098002) should have been called in to the agency in order to support existing 

indoor uses, but was not. Because the only study measuring the toxicity of LAS to freshwater 

invertebrates was determined to be supplemental, HPV Challenge Program data were used in 
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order to create a more comprehensive toxicity profile. The agency expects to obtain and review 

the specific data from the HPV Challenge Program in order to satisfy this data requirement 

(Table 13)..

Table 22 – Available Endpoints from Freshwater Invertebrate Ecotoxicity Studies for LAS

Study Type Species

Test 

material (% 

ai)

Toxicity1 Toxicity 

Classification MRID & Status

Acute – Freshwater 

Invertebrate Toxicity

(850.1010)

Waterflea 

(Daphnia 

magna)

Not reported

EC50:

LAS-C10 = 

29.5 mg/L

LAS-C12 = 

6.84 mg/L

LAS-C14 = 

0.80 mg/L

LAS-C16 = 

0.20 mg/L

Slightly to highly 

toxic

47025025

Supplemental

Estuarine and Marine Fish and Invertebrate Toxicity

Acute toxicity testing with estuarine and marine organisms using the TGAI is required when the 

end-use product is intended for direct application to the marine/estuarine environment or effluent 

containing the active ingredient is expected to reach this environment. Acute estuarine/marine 

tests are not expected to be required for ABS because the currently registered uses are primarily 

indoor applications and are not expected to reach estuarine/marine environments. 

Aquatic Plants

Table 23 – Available Endpoints from Freshwater Aquatic Plants

Study Type Species Test material (% 

ai) Toxicity1 Toxicity Classification

MRID & 

Status

Aquatic Plant 

Growth (Algal) 

Tier II (Dose 

Response)

(850.5400)

Freshwater Alga 

(Selenastrum 

capricornutum)

Sodium 

dodecylbenzene 

sulfonate 079010

96-hr EC50:

70.27 mg/L

Slightly to 

highly toxic

42439803

Supplemental

OPP received one toxicity study conducted on alga using sodium dodecylbenzene sulfonate (MRID 

42439803). The 1990 study was conducted according to the standard procedure from the Federal Register 

at the time (Vol. 50, Section 797.1050, Algal Acute Toxicity Test). A protocol, which provided limited 

information on the test system used, was provided in the Study Report. The Study Report did not include, 

however, the experimental observations (i.e., pH, temperature, dissolved oxygen), the raw data (i.e, cell 

counts, mean cell volume), or the dose responses in a tabular format (i.e., cell density, growth rate, 

biomass). This study was reviewed using EPA OPPTS Guideline 850.5400, but the review was hindered 

due to the lack of the above mentioned information. 
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• Because the only study measuring the toxicity of sodium dodecylbenzene sulfonate to 

alga was determined to be supplemental, HPV data were used in order to create a more 

comprehensive toxicity profile.
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Appendix E Comments Received 

Concerning the Preliminary Work Plan

The Agency received one comment on the initial docket, described below. In the PWP, the 

Agency solicited comments on specific topics: environmental justice, water body impairment, 

trade irritants, and structure activity relationships. No comments or information were received 

during the public comment period concerning these issues.

Comment: Diversey, Inc. reviewed the ABS PWP and requested corrections to Table 6 –

Summary of Registered Uses. The changes are based on the use sites, application methods and 

application rates.

Response: The agency has made all the applicable changes to all of the products identified in 

Table 6 - Summary of Registered Uses.